Food and Drug Administration

What is Food and Drug Administration known for?


controversial history

ANS01325.html archivedate December 21, 2005 Controversy over approval of Depo-Provera in the United States There was a long, controversial history regarding the approval of Depo-Provera by the U.S. Food and Drug Administration. The original manufacturer, Upjohn, applied repeatedly for approval. FDA advisory committees unanimously recommended approval in 1973, 1975 and 1992, as did the FDA's professional medical staff, but the FDA repeatedly denied approval. Ultimately, on October 29, 1992, the FDA approved Depo-Provera, which had by then been used by over 30 million women since 1969 and was approved and being used by nearly 9 million women in more than 90 countries, including the United Kingdom, France, Germany, Sweden, Thailand, New Zealand and Indonesia. In what the Food and Drug Administration (w:Food and Drug Administration) is characterizing as one of the largest recalls in recent history, numerous types of products containing peanuts (w:Peanut) are being recalled in the United States. The FDA issued a recall on Wednesday on food items with peanut paste and other peanut products made after January 1, 2007 at a Peanut Corp. of America (PCA) center in Blakely, Georgia (w:Blakely, Georgia). The recall affects over 430 products containing peanut paste or peanut butter from the PCA plant. The president announced the nomination of a new agency commissioner for the Food and Drug Administration (w:Food and Drug Administration) (FDA), former New York City (w:New York City) Health Commissioner Margaret Hamburg (w:Margaret Hamburg). According to the Food and Drug Administration (w:Food and Drug Administration) (FDA), inspections of Nipro facilities last October revealed problems with the needles, which could allow parts of silicone (w:silicone) in the port to be dislodged. 60%–72% of tested needles had that problem. In a conference call with reporters, FDA officials remarked that they were concerned the silicone could enter the bloodstream of a patient, although, to date, no harm from this has been reported.


single industry

in the Midwest and West. The progressives argued the need for government regulation of business practices to ensure competition and free enterprise. Congress enacted a law regulating railroads in 1887 (the Interstate Commerce Act), and one preventing large firms from controlling a single industry in 1890 (the Sherman Antitrust Act). These laws were not rigorously enforced, however, until the years between 1900 and 1920, when Republican President Theodore Roosevelt (1901–1909


time history

with dual NRTIs and a protease inhibitor (Protease inhibitor (pharmacology)) (PI) were not far off by this time. History Stavudine was first synthetized in the sixties by Jerome Horwitz. J.P. Horwitz et al.. J. Org. Chem. 31. 205 (1966). Oral account of the history of AZT (Zidovudine), d4T (Stavudine) and ddC (Zalcitabine) by Jerome Horwitz and Hiroaki Mitsuya in the documentary film I am alive today - History of an AIDS drug. It was subsequently reconsidered as an anti-HIV agent by the Rega Institute for Medical Research in Belgium. Stavudine was approved by the U.S. Food and Drug Administration (FDA) on June 24, 1994 for adults and on September 6, 1996 for pediatric use and again as an extended-release version for once-a-day dosing in 2001. The fourth antiretroviral drug on the market, its patent expired in the United States on 2008-06-25. Lamivudine was approved by the Food and Drug Administration (FDA) on November 17, 1995 for use with zidovudine (AZT) and again in 2002 as a once-a-day dosed medication. The fifth antiretroviral drug on the market, it was the last NRTI for three years while the approval process switched to protease inhibitors (protease inhibitor (pharmacology)). According to the manufacturer's 2004 annual report, its patent will expire in the United States in 2010 and in Europe in 2011. However, when the Food and Drug Administration (FDA) later presented more complete data from the CLASS and VIGOR trials on its web site, the results were less certain. The CLASS trial was revealed to also have twelve and fifteen month time points which had not been discussed in the JAMA publication; in this segment of the trial, the number of ulcer-related complications for Celebrex caught up to the control NSAID group. Similarly, the complete VIGOR study data revealed that in fact, when all adverse events, not just gastrointestinal, were tabulated, the patients receiving VIOXX had suffered (barely) significantly higher incidence of adverse events overall than the control NSAID group. In particular, the risk of serious cardiovascular thrombotic (thrombosis) events, e.g. myocardial infarction, was 1.7% in the VIOXX patients versus 0.7% in the control group, and there were significantly more withdrawals in the Vioxx group for causes including hypertension, edema, hepatotoxicity, heart failure, or pathological laboratory findings. The mean increases in systolic (Systole (medicine)) and diastolic blood pressure in the Vioxx group were 4.6 mmHg and 1.7 mmHg respectively, compared to 1.0 and 0.1 mmHg in the control NSAID group. An estimated 43,000,000 Americans, nearly one out of six, suffers from arthritis. However, 42% (18 million) of these also suffer from hypertension. Therefore, the promise of better patient outcomes and lowered medical costs from use of COX-2 inhibitors may not be as great as previously hoped. Questions remain regarding the relative safety and cost effectiveness of this new class. While endoscopic (endoscopy) evidence of gastrointestinal damage is frequently seen in studies of nonspecific NSAIDs, the actual incidence of clinically evident symptoms and patient discomfort is much lower; furthermore, in cases of short-term therapy, any such damage generally reverses itself quickly after termination of the drug. Studies have shown that buprenorphine is safer than methadone due to lower overdose related deaths due to the treatment. In what the Food and Drug Administration (w:Food and Drug Administration) is characterizing as one of the largest recalls in recent history, numerous types of products containing peanuts (w:Peanut) are being recalled in the United States. The FDA issued a recall on Wednesday on food items with peanut paste and other peanut products made after January 1, 2007 at a Peanut Corp. of America (PCA) center in Blakely, Georgia (w:Blakely, Georgia). The recall affects over 430 products containing peanut paste or peanut butter from the PCA plant. The president announced the nomination of a new agency commissioner for the Food and Drug Administration (w:Food and Drug Administration) (FDA), former New York City (w:New York City) Health Commissioner Margaret Hamburg (w:Margaret Hamburg). According to the Food and Drug Administration (w:Food and Drug Administration) (FDA), inspections of Nipro facilities last October revealed problems with the needles, which could allow parts of silicone (w:silicone) in the port to be dislodged. 60%–72% of tested needles had that problem. In a conference call with reporters, FDA officials remarked that they were concerned the silicone could enter the bloodstream of a patient, although, to date, no harm from this has been reported.


natural quot

non-traditional treatment that used coffee enemas, frequent shampoos, injection of live cells from cows and sheep, massage and laetrile (Amygdalin), a supposedly "natural" anti-cancer drug available in Mexico, but not approved by the U.S. Food and Drug Administration. McQueen was treated by William Donald Kelley, whose only medical license had been (until it was revoked in 1976) for orthodontics. Worthington, Roger

) or the major drug corporations). *'''Conspiracy theories (Conspiracy theory)''': Anti-quackery activists ("quackbusters") are accused of being part of a huge "conspiracy" to suppress "unconventional" and or "natural" therapies, as well as those who promote them. It is alleged that this conspiracy is backed and funded by the pharmaceutical industry and the established medical care system – represented by the AMA (American Medical Association), FDA (Food and Drug Administration), ADA (American Dental Association), CDC (Center for Disease Control and Prevention), WHO (World Health Organization), etc. – for the purpose of preserving their power and increasing their profits. In the case of chiropractic, the case for a conspiracy was supported by a court decision, ruling that the AMA had engaged in an unlawful conspiracy in restraint of trade "to contain and eliminate the chiropractic profession." In what the Food and Drug Administration (w:Food and Drug Administration) is characterizing as one of the largest recalls in recent history, numerous types of products containing peanuts (w:Peanut) are being recalled in the United States. The FDA issued a recall on Wednesday on food items with peanut paste and other peanut products made after January 1, 2007 at a Peanut Corp. of America (PCA) center in Blakely, Georgia (w:Blakely, Georgia). The recall affects over 430 products containing peanut paste or peanut butter from the PCA plant. The president announced the nomination of a new agency commissioner for the Food and Drug Administration (w:Food and Drug Administration) (FDA), former New York City (w:New York City) Health Commissioner Margaret Hamburg (w:Margaret Hamburg). According to the Food and Drug Administration (w:Food and Drug Administration) (FDA), inspections of Nipro facilities last October revealed problems with the needles, which could allow parts of silicone (w:silicone) in the port to be dislodged. 60%–72% of tested needles had that problem. In a conference call with reporters, FDA officials remarked that they were concerned the silicone could enter the bloodstream of a patient, although, to date, no harm from this has been reported.


food fast

caused it have been the source of much negative publicity for the Food and Drug Administration (FDA), meat industries, and fast-food restaurants (fast food) since the 1990s, especially in the Jack in the Box (Jack in the Box (restaurant)) contaminations. It was also featured in the Robin Cook (Robin Cook (novelist)) novel ''Toxin (Toxin (novel))''. In 2006, an epidemic of harmful ''E. coli'' emerged in the United States (2006 United States E. coli outbreak) due to contaminated


critical time

, but if you don't operate on him, the fetus dies and the patient dies, because a hemorrhage (w:Obstetrical hemorrhage) is a very very critical time for ectopic pregnancy (w:Ectopic pregnancy). I don't see any reason why you can't use that fetal tissue for research. ** Politico TV, May 2007 department oversees Medicare and w:Medicaid Medicaid for senior citizens, the safety of drugs and the nation's food supply through the w:Food and Drug


oil black

oil, black currant oil and combinations) were unapproved food additives. Kulow’s victory was significant because the Dietary Supplement Health and Education Act was altered to bar the FDA from using the "unapproved additive" argument to regulate dietary supplements. Toxicity There are no reported incidents of negative side effects of ''luohan guo''. It is classed by the US Food and Drug Administration as a GRAS (generally recognized as safe) product


products+related

marketing literature that certain products could help ward off the virus. In what the Food and Drug Administration (w:Food and Drug Administration) is characterizing as one of the largest recalls in recent history, numerous types of products containing peanuts (w:Peanut) are being recalled in the United States. The FDA issued a recall on Wednesday on food items with peanut paste and other peanut products made after January 1, 2007 at a Peanut Corp. of America (PCA) center in Blakely, Georgia (w:Blakely, Georgia). The recall affects over 430 products containing peanut paste or peanut butter from the PCA plant. The president announced the nomination of a new agency commissioner for the Food and Drug Administration (w:Food and Drug Administration) (FDA), former New York City (w:New York City) Health Commissioner Margaret Hamburg (w:Margaret Hamburg). According to the Food and Drug Administration (w:Food and Drug Administration) (FDA), inspections of Nipro facilities last October revealed problems with the needles, which could allow parts of silicone (w:silicone) in the port to be dislodged. 60%–72% of tested needles had that problem. In a conference call with reporters, FDA officials remarked that they were concerned the silicone could enter the bloodstream of a patient, although, to date, no harm from this has been reported.


study published

to a study published in the Journal of Public Policy & Marketing, without an interpretive footnote or further information on recommended daily value, many consumers do not know how to interpret the meaning of trans fat content on the Nutrition Facts panel. In fact, without specific prior knowledge about trans fat and its negative health effects, consumers, including those at risk for heart disease, may misinterpret nutrient information provided on the panel. In what the Food and Drug Administration (w:Food and Drug Administration) is characterizing as one of the largest recalls in recent history, numerous types of products containing peanuts (w:Peanut) are being recalled in the United States. The FDA issued a recall on Wednesday on food items with peanut paste and other peanut products made after January 1, 2007 at a Peanut Corp. of America (PCA) center in Blakely, Georgia (w:Blakely, Georgia). The recall affects over 430 products containing peanut paste or peanut butter from the PCA plant. The president announced the nomination of a new agency commissioner for the Food and Drug Administration (w:Food and Drug Administration) (FDA), former New York City (w:New York City) Health Commissioner Margaret Hamburg (w:Margaret Hamburg). According to the Food and Drug Administration (w:Food and Drug Administration) (FDA), inspections of Nipro facilities last October revealed problems with the needles, which could allow parts of silicone (w:silicone) in the port to be dislodged. 60%–72% of tested needles had that problem. In a conference call with reporters, FDA officials remarked that they were concerned the silicone could enter the bloodstream of a patient, although, to date, no harm from this has been reported.


physical performance

time and impairment of motor functions (including coordination (motor coordination) problems), slurred speech, decreased physical performance, numbed emotions

Food and Drug Administration

The '''Food and Drug Administration''' ('''FDA''' or '''USFDA''') is a federal agency (List of United States federal agencies) of the United States Department of Health and Human Services, one of the United States federal executive departments. The FDA is responsible for protecting and promoting public health through the regulation and supervision of food safety, tobacco products, dietary supplements, prescription (Prescription drug) and over-the-counter (Over-the-counter drug) pharmaceutical drugs (medications), vaccines, biopharmaceuticals, blood transfusions, medical devices, electromagnetic radiation emitting devices (ERED), cosmetics, animal foods & feed (Animal Feed) http: www.fda.gov AnimalVeterinary Products AnimalFoodFeeds default.htm and veterinary products (Veterinary medicine).

The FDA was empowered by the United States Congress to enforce the Federal Food, Drug, and Cosmetic Act, which serves as the primary focus for the Agency; the FDA also enforces other laws, notably Section 361 of the Public Health Service Act and associated regulations, many of which are not directly related to food or drugs. These include regulating lasers, cellular phones, condoms and control of disease on products ranging from certain household pets to sperm donation for assisted reproduction.

The FDA is led by the Commissioner of Food and Drugs, appointed by the President (President of the United States) with the advice and consent of the Senate (United States Senate). The Commissioner reports to the Secretary of Health and Human Services. The 21st and current Commissioner is Dr. Margaret A. Hamburg. She has served as Commissioner since May 2009.

The FDA has its headquarters in unincorporated White Oak, Maryland.

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