90-439: The king mackerel ( Scomberomorus cavalla ) surmayi or kingfish , is a migratory species of mackerel of the western Atlantic Ocean and Gulf of Mexico . It is an important species to both the commercial and recreational fishing industries. The king mackerel is a medium-sized fish, typically encountered from 5 kg (11 lb) to 14 kg (30 lb), but is known to exceed 40 kg (90 lb). The entire body
180-520: A diel vertical migration , staying in deeper water during the day and rising to the surface at night to feed. The young and juveniles also migrate vertically, but in the opposite direction, staying near the surface during the day and moving deeper at night. Mackerel are prolific broadcast spawners , and must breed near the surface of the water because the eggs of the females float. Individual females lay between 300,000 and 1,500,000 eggs. Their eggs and larvae are pelagic , that is, they float free in
270-720: A medical practitioner 's supervision like ibuprofen . In 2014, the FDA added an Ebola treatment being developed by Canadian pharmaceutical company Tekmira to the Fast Track program , but halted the phase 1 trials in July pending the receipt of more information about how the drug works. This was widely viewed as increasingly important in the face of a major outbreak of the disease in West Africa that began in late March 2014 and ended in June 2016. During
360-460: A "FDA Compliant" or "FDA Acceptable". Medical countermeasures (MCMs) are products such as biologics and pharmaceutical drugs that can protect from or treat the health effects of a chemical, biological, radiological, or nuclear (CBRN) attack. MCMs can also be used for prevention and diagnosis of symptoms associated with CBRN attacks or threats. The FDA runs a program called the "FDA Medical Countermeasures Initiative" (MCMi), with programs funded by
450-425: A REMS program called iPLEDGE . Generic drugs are chemical and therapeutic equivalents of name-brand drugs, normally whose patents have expired. Approved generic drugs should have the same dosage, safety, effectiveness, strength, stability, and quality, as well as route of administration. In general, they are less expensive than their name brand counterparts, are manufactured and marketed by rival companies and, in
540-745: A case. The FDA has a number of field offices across the United States, in addition to international locations in China, India, Europe, the Middle East, and Latin America. As of 2021, the FDA had responsibility for overseeing $ 2.7 trillion in food, medical, and tobacco products. Some 54% of its budget derives from the federal government, and 46% is covered by industry user fees for FDA services. For example, pharmaceutical firms pay fees to expedite drug reviews. According to Forbes, pharmaceutical firms provide 75% of
630-513: A company may advertise or promote a drug only for the specific indication or medical use for which it was approved by FDA. Also, an advertisement must contain a "fair balance" between the benefits and the risks (side effects) of a drug. The regulation of drug advertising in the U.S. is divided between the Food and Drug Administration (FDA) and the Federal Trade Commission (FTC), based on whether
720-426: A complaint brought against the FDA by Mylan Laboratories Inc. of Pittsburgh . When its application to manufacture generics were subjected to repeated delays by the FDA, Mylan, convinced that it was being discriminated against, soon began its own private investigation of the agency in 1987. Mylan eventually filed suit against two former FDA employees and four drug-manufacturing companies, charging that corruption within
810-731: A conventional or spinning reel capable of holding 340 m (370 yd) of 13 kg (29 lb) test monofilament and a 2 m (6 ft 7 in), 13 kg (29 lb) class rod. Several organizations have found success in promoting tournament events for this species because of their popularity as a sport fish. The most notable are the Southern Kingfish Association (SKA) and the FLW Outdoors tour. These events are covered in several outdoors publications, both in print and online. As of 2005, king mackerel are primarily marketed fresh. They may be sold as fillets, steaks, or in
900-432: A long period of time. The studies are progressively longer, gradually adding more individuals as they progress from stage I to stage III, normally over a period of years, and normally involve drug companies, the government and its laboratories, and often medical schools and hospitals and clinics. However, any exceptions to the aforementioned process are subject to strict review and scrutiny and conditions, and are only given if
990-555: A new master plan for this expansion in December 2018, and construction is expected to be completed by 2035, dependent on GSA appropriations. The Office of Regulatory Affairs is considered the agency's "eyes and ears", conducting the vast majority of the FDA's work in the field. Its employees, known as Consumer Safety Officers, or more commonly known simply as investigators, inspect production, warehousing facilities, investigate complaints, illnesses, or outbreaks, and review documentation in
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#17331065865571080-647: A number of Resident Posts, which are FDA remote offices that serve a particular geographic area. ORA also includes the Agency's network of regulatory laboratories, which analyze any physical samples taken. Though samples are usually food-related, some laboratories are equipped to analyze drugs, cosmetics, and radiation-emitting devices. The Office of Criminal Investigations was established in 1991 to investigate criminal cases. To do so, OCI employs approximately 200 Special Agents nationwide who, unlike ORA Investigators, are armed, have badges, and do not focus on technical aspects of
1170-831: A result of this trend, many UK fishmongers during the 1970s did not display or even stock mackerel. United States Food and Drug Administration The United States Food and Drug Administration ( FDA or US FDA ) is a federal agency of the Department of Health and Human Services . The FDA is responsible for protecting and promoting public health through the control and supervision of food safety , tobacco products, caffeine products, dietary supplements , prescription and over-the-counter pharmaceutical drugs (medications), vaccines , biopharmaceuticals , blood transfusions , medical devices , electromagnetic radiation emitting devices (ERED), cosmetics, animal foods & feed and veterinary products . The FDA's primary focus
1260-494: A role in monitoring safety through influence on ingredients, but they lack legal authority. According to the ACSH, it has reviewed about 1,200 ingredients and has suggested that several hundred be restricted—but there is no standard or systemic method for reviewing chemicals for safety, or a clear definition of what 'safety' even means so that all chemicals get tested on the same basis. However, on December 29, 2022, President Biden signed
1350-523: A satisfied requirement. The FDA does not approve applied coatings used in the food processing industry . There is no review process to approve the composition of nonstick coatings; nor does the FDA inspect or test these materials. Through their governing of processes, however, the FDA does have a set of regulations that cover the formulation, manufacturing, and use of nonstick coatings. Hence, materials like Polytetrafluoroethylene (Teflon) are not and cannot be considered as FDA Approved, but rather, they are
1440-436: A strong metal leader. The first may be a treble or single and is hooked through the live bait's nose and/or mouth. The second hook (treble hook) is placed through the top of the fish's back or allowed to swing free. This must be done because king mackerel commonly bite the tail section of a bait fish. When trolling for kings using this method, it is important to make sure the baitfish are swimming properly. Typical tackle includes
1530-440: A substantial amount of research and at least some preliminary human testing has shown that they are believed to be somewhat safe and possibly effective. (See FDA Special Protocol Assessment about Phase III trials.) The FDA's Office of Prescription Drug Promotion (OPDP) has responsibilities that revolve around the review and regulation of prescription drug advertising and promotion. This is achieved through surveillance activities and
1620-553: A warning to that effect. According to the industry advocacy group, the American Council on Science and Health , though the cosmetic industry is primarily responsible for its own product safety, the FDA can intervene when necessary to protect the public. In general, though, cosmetics do not require pre-market approval or testing. The ACSH says that companies must place a warning note on their products if they have not been tested, and that experts in cosmetic ingredient review also play
1710-401: Is a center of the FDA that regulates food additives and drugs that are given to animals. CVM regulates animal drugs, animal food including pet animal, and animal medical devices. The FDA's requirements to prevent the spread of bovine spongiform encephalopathy are also administered by CVM through inspections of feed manufacturers. CVM does not regulate vaccines for animals; these are handled by
1800-549: Is a common name applied to a number of different species of pelagic fish , mostly from the family Scombridae . They are found in both temperate and tropical seas, mostly living along the coast or offshore in the oceanic environment. Mackerel species typically have deeply forked tails and vertical " tiger -like" stripes on their backs with an iridescent green-blue quality. Many are restricted in their distribution ranges and live in separate populations or fish stocks based on geography. Some stocks migrate in large schools along
1890-651: Is a separate process, and the drug must be approved through an NDA first. A drug that is approved is said to be "safe and effective when used as directed". Very rare, limited exceptions to this multi-step process involving animal testing and controlled clinical trials can be granted out of compassionate use protocols. This was the case during the 2015 Ebola epidemic with the use, by prescription and authorization, of ZMapp and other experimental treatments, and for new drugs that can be used to treat debilitating and/or very rare conditions for which no existing remedies or drugs are satisfactory, or where there has not been an advance in
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#17331065865571980-721: Is a subtropical species of the Atlantic Coast of the Americas. Common in the coastal zone from North Carolina to Brazil , it occurs as far south as Rio de Janeiro , and occasionally as far north as the Gulf of Maine and found in Western coast of India predominantly in the Arabian Sea as well as in the East coast of India Bay of Bengal , Indian Ocean . Nonetheless, a preference for water temperatures in
2070-628: Is almost certainly a female. King mackerel are voracious, opportunistic carnivores. Their prey depends on their size. Depending on area and season, they favor squid, menhaden and other sardine -like fish ( Clupeidae ), jacks ( Carangidae ), cutlassfish ( Trichiuridae ), weakfish ( Sciaenidae ), grunts ( Haemulidae ), striped anchovies ( Engraulidae ), cigar minnows, threadfin, northern mackerel, and blue runners . They do not attack humans but will defend themselves against perceived threats, including humans flailing or thrashing in man-overboard and similar situations, by biting. King mackerel are among
2160-409: Is an example of a larger mackerel. Most fish are cold-blooded , but exceptions exist. Certain species of fish maintain elevated body temperatures. Endothermic bony fishes are all in the suborder Scombroidei and include the butterfly mackerel , a species of primitive mackerel. Mackerel are strong swimmers. Known in the latin family as "punctualis piscis" which translates to "punctual fish." This
2250-454: Is consumed worldwide. As an oily fish , it is a rich source of omega-3 fatty acids . The flesh of mackerel spoils quickly, especially in the tropics, and can cause scombroid food poisoning . Accordingly, it should be eaten on the day of capture, unless properly refrigerated or cured . Mackerel preservation is not simple. Before the 19th-century development of canning and the widespread availability of refrigeration, salting and smoking were
2340-404: Is covered with very small, hardly visible, loosely attached scales. The first (spiny) dorsal fin is entirely colorless and is normally folded back into a body groove, as are the pelvic fins . The lateral line starts high on the shoulder, dips abruptly at mid-body and then continues as a wavy horizontal line to the tail. Coloration is olive on the back, fading to silver with a rosy iridescence on
2430-588: Is divided equally between the Atlantic mackerel and all other scombroid mackerels. Just these two species (Chub mackerel and Atlantic mackerel) account for about 75% of the total catch of scombroid mackerels. Chilean jack mackerel are the most commonly fished nonscombroid mackerel, fished as heavily as chub mackerel. The species has been overfished , and its fishery may now be in danger of collapsing. Smaller mackerel behave like herrings , and are captured in similar ways. Fish species like these, which school near
2520-445: Is due to its punctuality of migration during mating season as it moves from warm to cold waters. Atlantic mackerel can swim at a sustained speed of 0.98 m/sec with a burst speed of 5.5 m/sec, while chub mackerel can swim at a sustained speed of 0.92 m/sec with a burst speed of 2.25 m/sec. Most mackerel species have restricted distribution ranges. Some mackerel species migrate vertically. Adult snake mackerel conduct
2610-547: Is enforcement of the Federal Food, Drug, and Cosmetic Act (FD&C). However, the agency also enforces other laws, notably Section 361 of the Public Health Service Act as well as associated regulations. Much of this regulatory-enforcement work is not directly related to food or drugs but involves other factors like regulating lasers , cellular phones , and condoms . In addition, the FDA takes control of diseases in
2700-466: Is high in omega-3 oils and is intensively harvested by humans. In 2009, over 5 million tons were landed by commercial fishermen. Sport fishermen value the fighting abilities of the king mackerel . Over 30 different species, principally belonging to the family Scombridae , are commonly referred to as mackerel. The term "mackerel" is derived from Old French and may have originally meant either "marked, spotted" or "pimp, procurer". The latter connection
2790-713: Is located in the White Oak area of Silver Spring, Maryland . The agency has 223 field offices and 13 laboratories located across the 50 states, the United States Virgin Islands , and Puerto Rico . In 2008, the FDA began to post employees to foreign countries, including China, India, Costa Rica, Chile, Belgium, and the United Kingdom. FDA headquarters facilities are currently located in Montgomery County and Prince George's County , Maryland. Since 1990,
King mackerel - Misplaced Pages Continue
2880-470: Is not altogether clear, but mackerel spawn enthusiastically in shoals near the coast, and medieval ideas on animal procreation were creative. About 21 species in the family Scombridae are commonly called mackerel. The type species for the scombroid mackerel is the Atlantic mackerel , Scomber scombrus . Until recently, Atlantic chub mackerel and Indo-Pacific chub mackerel were thought to be subspecies of
2970-499: Is not the case, though, because mackerel live in midwater pelagic environments which have no background. However, fish have an optokinetic reflex in their visual systems that can be sensitive to moving stripes. For fish to school efficiently, they need feedback mechanisms that help them align themselves with adjacent fish, and match their speed. The stripes on neighbouring fish provide "schooling marks", which signal changes in relative position. A layer of thin, reflecting platelets
3060-586: Is seen on some of the mackerel stripes. In 1998, E J Denton and D M Rowe argued that these platelets transmit additional information to other fish about how a given fish moves. As the orientation of the fish changes relative to another fish, the amount of light reflected to the second fish by this layer also changes. This sensitivity to orientation gives the mackerel "considerable advantages in being able to react quickly while schooling and feeding." Mackerel range in size from small forage fish to larger game fish . Coastal mackerel tend to be small. The king mackerel
3150-449: Is the branch of the FDA responsible for ensuring the safety and efficacy of biological therapeutic agents. These include blood and blood products, vaccines, allergenics, cell and tissue-based products, and gene therapy products. New biologics are required to go through a premarket approval process called a Biologics License Application (BLA), similar to that for drugs. The original authority for government regulation of biological products
3240-737: Is the branch of the FDA responsible for the premarket approval of all medical devices , as well as overseeing the manufacturing, performance and safety of these devices. The definition of a medical device is given in the FD&;C Act, and it includes products from the simple toothbrush to complex devices such as implantable neurostimulators . CDRH also oversees the safety performance of non-medical devices that emit certain types of electromagnetic radiation . Examples of CDRH-regulated devices include cellular phones , airport baggage screening equipment , television receivers , microwave ovens , tanning booths , and laser products . CDRH regulatory powers include
3330-696: Is used for a different purpose, or undergoes any substantial change. The most rigorous requirements apply to new molecular entities : drugs that are not based on existing medications. New drugs receive extensive scrutiny before FDA approval in a process called a new drug application (NDA). Under the Presidency of Donald Trump , the agency has worked to make the drug-approval process go faster. Critics, however, argue that FDA standards are not sufficiently rigorous to prevent unsafe or ineffective drugs from getting approval. New drugs are available only by prescription by default. A change to over-the-counter (OTC) status
3420-451: Is voluntary. While this remains the primary tool of post-market safety surveillance , FDA requirements for post-marketing risk management are increasing. As a condition of approval, a sponsor may be required to conduct additional clinical trials , called Phase IV trials. In some cases, the FDA requires risk management plans called Risk Evaluation and Mitigation Strategies (REMS) for some drugs that require actions to be taken to ensure that
3510-671: The Center for Drug Evaluation and Research (CDER), the Center for Devices and Radiological Health (CDRH), the Center for Biologics Evaluation and Research (CBER) and offices for the Center for Veterinary Medicine (CVM). With the passing of the FDA Reauthorization Act of 2017, the FDA projects a 64% increase in employees to 18,000 over the next 15 years and wants to add approximately 1,600,000 square feet (150,000 square metres) of office and special use space to their existing facilities. The National Capital Planning Commission approved
3600-531: The Gulf of Mexico , the Caribbean Sea , and the US Southeast Atlantic. Overfishing of king and Spanish mackerel occurred in the 1980s. Regulations were introduced to restrict the size, fishing locations, and bag limits for recreational fishers and commercial fishers. Gillnets were banned in waters off Florida. By 2001, the mackerel stocks had bounced back. Mackerel is an important food fish that
3690-454: The Pacific jack mackerel ( Trachurus symmetricus ) and the heavily harvested Chilean jack mackerel ( T. murphyi ). These have been thought at times to be the same species, but are now recognised as separate species. The term "mackerel" is also used as a modifier in the common names of other fish, sometimes indicating the fish has vertical stripes similar to a scombroid mackerel: By extension,
King mackerel - Misplaced Pages Continue
3780-639: The coronavirus pandemic , FDA granted emergency use authorization for personal protective equipment (PPE), in vitro diagnostic equipment, ventilators and other medical devices. On March 18, 2020, FDA inspectors postponed most foreign facility inspections and all domestic routine surveillance facility inspections. In contrast, the USDA's Food Safety and Inspection Service (FSIS) continued inspections of meatpacking plants, which resulted in 145 FSIS field employees who tested positive for COVID-19, and three who died. The Center for Biologics Evaluation and Research
3870-478: The dorsal and ventral sides behind the dorsal and anal fins , but unlike the deep-bodied tuna, they are slim. The type species for scombroid mackerels is the Atlantic mackerel, Scomber scombrus . These fish are iridescent blue-green above with a silvery underbelly and near-vertical wavy black stripes running along their upper bodies. The prominent stripes on the back of mackerels seemingly are there to provide camouflage against broken backgrounds. That
3960-606: The '2023 Consolidated Budget Act', which includes the 'Cosmetics Regulatory Modernization Act of 2022 (MoCRA)', which is a stricter regulation that is different from the previous regulations. MoCRA requires compliance with matters such as serious adverse event reporting, safety substantiation, additional labeling, record keeping, and Good Manufacturing Practices (GMP). MoCRA also calls on the FDA to grant Mandatory Recall Authority and establish regulations for GMP rules, flavor allergen labeling rules, and testing methods for cosmetics containing talc. The Center for Veterinary Medicine (CVM)
4050-406: The 1990s, accounted for about a third of all prescriptions written in the United States. For a pharmaceutical company to gain approval to produce a generic drug, the FDA requires scientific evidence that the generic drug is interchangeable with or therapeutically equivalent to the originally approved drug. This is called an Abbreviated New Drug Application (ANDA). 80% of prescription drugs sold in
4140-501: The FD&C Act. OCI Special Agents often come from other criminal investigations backgrounds, and frequently work closely with the Federal Bureau of Investigation , Assistant Attorney General , and even Interpol . OCI receives cases from a variety of sources—including ORA, local agencies, and the FBI, and works with ORA Investigators to help develop the technical and science-based aspects of
4230-622: The FDA exercises differ from one category to the next. Furthermore, legislation had granted the FDA a variety of means to address violations of standards for a given substance category. Under the Dietary Supplement Health and Education Act of 1994 (DSHEA), the FDA is responsible for ensuring that manufacturers and distributors of dietary supplements and dietary ingredients meet the current requirements. These manufacturers and distributors are not allowed to advertise their products in an adulterated way, and they are responsible for evaluating
4320-687: The FDA has had employees and facilities on 130 acres (53 hectares) of the White Oak Federal Research Center in the White Oak area of Silver Spring, Maryland . In 2001, the General Services Administration (GSA) began new construction on the campus to consolidate the FDA's 25 existing operations in the Washington metropolitan area , its headquarters in Rockville , and several fragmented office buildings. The first building,
4410-703: The FDA released a statement regarding new guidelines to help food and drug manufacturers "implement protections against potential attacks on the U.S. food supply". One of the guidelines includes the Intentional Adulteration (IA) rule, which requires strategies and procedures by the food industry to reduce the risk of compromise in facilities and processes that are significantly vulnerable. The FDA also uses tactics of regulatory shaming, mainly through online publication of non-compliance, warning letters, and "shaming lists." Regulation by shaming harnesses firms' sensitivity to reputational damage. For example, in 2018,
4500-581: The FDA's drug review budget Emergency Use Authorization (EUA) is a mechanism that was created to facilitate the availability and use of medical countermeasures, including vaccines and personal protective equipment, during public health emergencies such as the Zika virus epidemic, the Ebola virus epidemic and the COVID-19 pandemic. The programs for safety regulation vary widely by the type of product, its potential risks, and
4590-871: The Food and Drug Administration is governed by various statutes enacted by the United States Congress and interpreted by the FDA. Pursuant to the Federal Food, Drug, and Cosmetic Act and accompanying legislation, the FDA has authority to oversee the quality of substances sold as food in the United States, and to monitor claims made in the labeling of both the composition and the health benefits of foods. The FDA subdivides substances that it regulates as food into various categories—including foods, food additives , added substances (human-made substances that are not intentionally introduced into food, but nevertheless end up in it), and dietary supplements . Dietary supplements or dietary ingredients include vitamins, minerals, herbs, amino acids , and enzymes . Specific standards
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#17331065865574680-623: The Life Sciences Laboratory, was dedicated and opened with 104 employees in December 2003. As of December 2018, the FDA campus has a population of 10,987 employees housed in approximately 3,800,000 square feet (350,000 square metres) of space, divided into ten offices and four laboratory buildings. The campus houses the Office of the Commissioner (OC), the Office of Regulatory Affairs (ORA),
4770-477: The United States are generic brands. In 1989, a major scandal erupted involving the procedures used by the FDA to approve generic drugs for sale to the public. Charges of corruption in generic drug approval first emerged in 1988 during the course of an extensive congressional investigation into the FDA. The oversight subcommittee of the United States House Energy and Commerce Committee resulted from
4860-757: The agency published an online "black list", in which it named dozens of branded drug companies that are supposedly using unlawful or unethical means to attempt to impede competition from generic drug companies. The FDA frequently works with other federal agencies, including the Department of Agriculture , the Drug Enforcement Administration , Customs and Border Protection , and the Consumer Product Safety Commission . They also often work with local and state government agencies in performing regulatory inspections and enforcement actions. The regulation of food and dietary supplements by
4950-468: The authority to require certain technical reports from the manufacturers or importers of regulated products, to require that radiation-emitting products meet mandatory safety performance standards, to declare regulated products defective, and to order the recall of defective or noncompliant products. CDRH also conducts limited amounts of direct product testing. Clearance requests are required for medical devices that prove they are "substantially equivalent" to
5040-473: The case of medical devices, drugs, biological products, and other items where it may be difficult to conduct a physical examination or take a physical sample of the product. The Office of Regulatory Affairs is divided into five regions, which are further divided into 20 districts. The districts are based roughly on the geographic divisions of the Federal court system . Each district comprises a main district office and
5130-471: The centerline. Young king mackerel have similar, but slightly smaller spots, these fade away on individuals weighing over 5 kg (10 lb), but may still be seen as slightly darker green spots toward the back from some angles of view. Worldwide, many fish of these three species are quite similar to one or another. Off Mexico, Atlantic Spanish mackerel may be confused with Serra Spanish mackerel , Scomberomorus brasiliensis . Mackerel Mackerel
5220-645: The coast to suitable spawning grounds, where they spawn in fairly shallow waters. After spawning they return the way they came in smaller schools to suitable feeding grounds, often near an area of upwelling . From there they may move offshore into deeper waters and spend the winter in relative inactivity. Other stocks migrate across oceans. Smaller mackerel are forage fish for larger predators, including larger mackerel and Atlantic cod . Flocks of seabirds, whales, dolphins, sharks, and schools of larger fish such as tuna and marlin follow mackerel schools and attack them in sophisticated and cooperative ways. Mackerel flesh
5310-429: The consequent risk of mercury poisoning . Small king mackerel are similar in appearance to Atlantic Spanish mackerel , Scomberomorus maculatus , and cero mackerel , Scomberomorus regalis , all three species being similar in shape and coloration. They may be distinguished as follows: The lateral line on Atlantic Spanish mackerel and cero slopes gradually from the top edge of the gill to the tail. In contrast, that of
5400-502: The contexts varying from household pets to human sperm donated for use in assisted reproduction . The FDA is led by the commissioner of Food and Drugs , appointed by the President with the advice and consent of the Senate . The commissioner reports to the secretary of health and human services . Robert Califf is the current commissioner as of February 17, 2022. The FDA's headquarters
5490-618: The country. For many years mackerel was regarded as 'unclean' in the UK and other places due to folklore which suggested that the fish fed on the corpses of dead sailors. A 1976 survey of housewives in Britain undertaken by the White Fish Authority indicated a reluctance to departing from buying the traditional staples of cod, haddock or salmon. Less than 10% of the survey's 1,931 respondents had ever bought mackerel, and only 3% did so regularly. As
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#17331065865575580-466: The drug in question is a prescription drug or an over-the-counter (OTC) drug. The FDA oversees the advertising of prescription drugs, while the FTC regulates the advertising of OTC drugs. The term off-label refers to the practice of prescribing a drug for a different purpose than what the FDA approved. Due to this approval requirement, manufacturers were prohibited from advertising COVID-19 vaccines during
5670-416: The drug is used safely. For example, thalidomide can cause birth defects, but has uses that outweigh the risks if men and women taking the drugs do not conceive a child; a REMS program for thalidomide mandates an auditable process to ensure that people taking the drug take action to avoid pregnancy; many opioid drugs have REMS programs to avoid addiction and diversion of drugs. The drug isotretinoin has
5760-678: The early 1990s, the U.S. Securities and Exchange Commission filed securities fraud charges against the Bolar Pharmaceutical Company, a major generic manufacturer based in Long Island, New York. Over-the-counter (OTC) are drugs like aspirin that do not require a doctor's prescription. The FDA has a list of approximately 800 such approved ingredients that are combined in various ways to create more than 100,000 OTC drug products. Many OTC drug ingredients had been previously approved prescription drugs now deemed safe enough for use without
5850-648: The federal agency resulted in racketeering and in violations of antitrust law . "The order in which new generic drugs were approved was set by the FDA employees even before drug manufacturers submitted applications" and, according to Mylan, this illegal procedure was followed to give preferential treatment to certain companies. During the summer of 1989, three FDA officials (Charles Y. Chang, David J. Brancato, Walter Kletch) pleaded guilty to criminal charges of accepting bribes from generic drugs makers, and two companies ( Par Pharmaceutical and its subsidiary Quad Pharmaceuticals) pleaded guilty to giving bribes. Furthermore, it
5940-436: The federal government. It helps support "partner" agencies and organisations prepare for public health emergencies that could require MCMs. The Center for Drug Evaluation and Research uses different requirements for the three main drug product types: new drugs, generic drugs, and over-the-counter drugs. A drug is considered "new" if it is made by a different manufacturer, uses different excipients or inactive ingredients,
6030-545: The issuance of enforcement letters to pharmaceutical manufacturers. Advertising and promotion for over-the-counter drugs is regulated by the Federal Trade Commission . The FDA also implements regulatory oversight through engagement with third-party enforcer-firms. It expects pharmaceutical companies to ensure that third-party suppliers and labs comply with the agency's health and safety guidelines . The drug advertising regulation contains two broad requirements: (1)
6120-476: The king mackerel takes an abrupt drop at mid-body (see illustration). The first (spiny) dorsal fin on Atlantic Spanish mackerel and cero has a prominent black patch. The king mackerel does not. As all three species normally keep the first dorsal folded back in a body groove, this difference is not immediately evident. Atlantic Spanish mackerel have prominent yellow spots on the flanks at all sizes. In addition to such spots, cero have one or more yellow stripes along
6210-566: The most sought-after gamefish throughout their range from North Carolina to Texas. Known throughout the sportfishing world for their blistering runs, the king mackerel matches its distant relative, the wahoo, in speed. They are taken mostly by trolling, using various live and dead baitfish, spoons, jigs and other artificial lures. Commercial gear consists of run-around gill nets. They are also taken commercially by trolling with large planers, heavy tackle and lures similar to those used by sport fishers. Typically when using live bait, two hooks are tied to
6300-550: The northern part of their range in the summer and to the southern part in the winter, swimming in large schools. Both the South Atlantic and Gulf of Mexico stocks congregate in a winter mixing zone in an area of Monroe County, Florida, south of the Florida Keys, between November and March. Eggs and sperm are shed into the sea and their union is by chance. Depending on size, a female may shed from 50,000 to several million eggs over
6390-490: The open sea. The larvae and juvenile mackerel feed on zooplankton . As adults, they have sharp teeth, and hunt small crustaceans such as copepods , forage fish , shrimp , and squid . In turn, they are hunted by larger pelagic animals such as tuna, billfish , sea lions, sharks , and pelicans . Off Madagascar, spinner sharks follow migrating schools of mackerel. Bryde's whales feed on mackerel when they can find them. They use several feeding methods, including skimming
6480-533: The period in which they had only been approved under Emergency Use Authorization . After NDA approval, the sponsor must then review and report to the FDA every single patient adverse drug experience it learns of. They must report unexpected serious and fatal adverse drug events within 15 days, and other events on a quarterly basis. The FDA also receives directly adverse drug event reports through its MedWatch program. These reports are called "spontaneous reports" because reporting by consumers and health professionals
6570-422: The predicate devices already on the market. Approved requests are for items that are new or substantially different and need to demonstrate "safety and efficacy", for example they may be inspected for safety in case of new toxic hazards. Both aspects need to be proved or provided by the submitter to ensure proper procedures are followed. Cosmetics are regulated by the Center for Food Safety and Applied Nutrition ,
6660-560: The principal preservation methods available. Historically in England, this fish was not preserved, but was consumed only in its fresh form. However, spoilage was common, leading the authors of The Cambridge Economic History of Europe to remark: "There are more references to stinking mackerel in English literature than to any other fish!" In France, mackerel was traditionally pickled with large amounts of salt, which allowed it to be sold widely across
6750-564: The range of 20 to 29 °C (68 to 84 °F) may limit distribution. King mackerel commonly occur in depths of 12–45 m (40–150 ft), where the principal fisheries occur. Larger kings (heavier than 9 kg or 20 lb) often occur inshore, in the mouths of inlets and harbors, and occasionally even at the 180 m (590 ft) depths at the edge of the Gulf Stream . King mackerel migrate with seasonal changes in water temperature and with changes in food availability. They migrate to
6840-566: The regulated industries. Rather, OCI agents pursue and develop cases when individuals and companies commit criminal actions, such as fraudulent claims or knowingly and willfully shipping known adulterated goods in interstate commerce. In many cases, OCI pursues cases involving violations of Title 18 of the United States Code (e.g., conspiracy, false statements, wire fraud, mail fraud), in addition to prohibited acts as defined in Chapter III of
6930-470: The regulatory powers granted to the agency. For example, the FDA regulates almost every facet of prescription drugs, including testing, manufacturing, labeling, advertising, marketing, efficacy, and safety—yet FDA regulation of cosmetics focuses primarily on labeling and safety. The FDA regulates most products with a set of published standards enforced by a modest number of facility inspections. Inspection observations are documented on Form 483 . In June 2018,
7020-497: The round (whole). Their raw flesh is grayish, due to its high fat content. They are best prepared by grilling, frying, baking or, especially for large "smoker" king, by smoking. According to the United States Food and Drug Administration , king mackerel is one of four fishes, along with swordfish , shark , and tilefish , that children and pregnant women should avoid due to high levels of methylmercury found in these fish and
7110-448: The safety and labeling of their product. The FDA has a "Dietary Supplement Ingredient Advisory List" that includes ingredients that sometimes appear on dietary supplements but need further evaluation. An ingredient is added to this list when it is excluded from use in a dietary supplement, does not appear to be an approved food additive or recognized as safe, and/or is subjected to the requirement for pre-market notification without having
7200-458: The same branch of the FDA that regulates food. Cosmetic products are not, in general, subject to premarket approval by the FDA unless they make "structure or function claims" that make them into drugs (see Cosmeceutical ). However, all color additives must be specifically FDA approved before manufacturers can include them in cosmetic products sold in the U.S. The FDA regulates cosmetics labeling, and cosmetics that have not been safety tested must bear
7290-469: The same species. In 1999, Collette established, on molecular and morphological considerations, that these are separate species. Mackerel are smaller with shorter lifecycles than their close relatives, the tuna , which are also members of the same family. The true mackerels belong to the tribe Scombrini . The tribe consists of seven species, each belonging to one of two genera : Scomber or Rastrelliger . The Spanish mackerels belong to
7380-463: The sides, fading to white on the belly. Fish under 5 kg (11 lb) show yellowish-brown spots on the flanks, somewhat smaller than the spots of the Atlantic Spanish mackerel , Scomberomorus maculatus . Its cutting-edged teeth are large, uniform, closely spaced and flattened from side to side. These teeth look very similar to those of the bluefish , Pomatomus saltatrix . The king mackerel
7470-521: The spawning season. Fertilized eggs hatch in about 24 hours. The newly hatched larva is about 2.5 mm (0.098 in) long with a large yolk sack. Little is known about king mackerel in their first year of life. Yearling fish typically attain an average weight of 1.4–1.8 kg (3.1–4.0 lb) and a fork length of 60 cm (24 in). At age seven, females average 10 kg (22 lb), males 5 kg (11 lb). King mackerel may attain 40 kg (88 lb), but any over 7 kg (15 lb)
7560-615: The surface , lunging , and bubble nets . Chub mackerel, Scomber japonicus , are the most intensively fished scombroid mackerel. They account for about half the total capture production of scombroid mackerels. As a species, they are easily confused with Atlantic mackerel. Chub mackerel migrate long distances in oceans and across the Mediterranean. They can be caught with drift nets and suitable trawls , but are most usually caught with surround nets at night by attracting them with lampara lamps. The remaining catch of scombroid mackerels
7650-407: The surface, can be caught efficiently by purse seining. Huge purse-seine vessels use spotter planes to locate the schooling fish. Then they close in using sophisticated sonar to track the shape of the school, which is then encircled with fast auxiliary boats that deploy purse seines as they speed around the school. Suitably designed trollers can also catch mackerels effectively when they swim near
7740-409: The surface. Trollers typically have several long booms which they lift and drop with "topping lifts". They haul their lines with electric or hydraulic reels. Fish aggregating devices are also used to target mackerel. The North Sea has been overfished to the point where the ecological balance has become disrupted and many jobs in the fishing industry have been lost. The Southeast US region spans
7830-690: The term is applied also to other species such as the mackerel tabby cat , and to inanimate objects such as the altocumulus mackerel sky cloud formation. Most mackerel belong to the family Scombridae, which also includes tuna and bonito . Generally, mackerel are much smaller and slimmer than tuna, though in other respects, they share many common characteristics. Their scales , if present at all, are extremely small. Like tuna and bonito, mackerel are voracious feeders, and are swift and manoeuvrable swimmers, able to streamline themselves by retracting their fins into grooves on their bodies. Like other scombroids, their bodies are cylindrical with numerous finlets on
7920-487: The tribe Scomberomorini , which is the "cousin tribe" of the true mackerels. This tribe consists of 21 species in all—18 of those are classified into the genus Scomberomorus , two into Grammatorcynus , and a single species into the monotypic genus Acanthocybium . In addition, a number of species with mackerel-like characteristics in the families Carangidae , Hexagrammidae and Gempylidae are commonly referred to as mackerel. Some confusion had occurred between
8010-533: Was discovered that several manufacturers had falsified data submitted in seeking FDA authorization to market certain generic drugs. Vitarine Pharmaceuticals of New York, which sought approval of a generic version of the drug Dyazide , a medication for high blood pressure, submitted Dyazide, rather than its generic version, for the FDA tests. In April 1989, the FDA investigated 11 manufacturers for irregularities; and later brought that number up to 13. Dozens of drugs were eventually suspended or recalled by manufacturers. In
8100-534: Was established by the 1902 Biologics Control Act , with additional authority established by the 1944 Public Health Service Act . Along with these Acts, the Federal Food, Drug, and Cosmetic Act applies to all biologic products, as well. Originally, the entity responsible for regulation of biological products resided under the National Institutes of Health ; this authority was transferred to the FDA in 1972. The Center for Devices and Radiological Health (CDRH)
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