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Topic: FDA

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Food and Drug Administration

Schedule II

NDC

Pharmacokinetics

Controlled Substances Act

Pharmacodynamics

Vioxx

Orange Book

Food irradiation

Randomized controlled trial

Informed consent

Demerol

First Amendment to the United States Constitution

Tylenol scare

Chinese medicine

In the News (Fri 25 Jul 08)

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	U.S. FDA CDER Home Page
		FDA approves the first generic versions of Coreg (carvedilol).
		FDA approves Somatuline Depot (lanreotide acetate injection) for the treatment of acromegaly.
		FDA approves Risperdal (risperidone) for two psychiatric conditions in children and adolescents.
	www.fda.gov /cder (137 words)

	Food and Drug Administration - Wikipedia, the free encyclopedia
		The FDA is monitored by the Department of Health and Human Services (DHHS), which itself is part of the Executive Office branch of the United States government.
		The FDA is divided into five major Centers: the Center for Biologics Evaluation and Research (CBER), the Center for Devices and Radiological Health (CDRH), the Center for Drug Evaluation and Research (CDER), the Center for Food Safety and Applied Nutrition (CFSAN) and the Center for Veterinary Medicine (CVM).
		The FDA was also criticized for banning the essential amino acid Tryptophan after a manufacturing incident in Japan contaminated one batch.
	en.wikipedia.org /wiki/FDA (2455 words)

	Operation Cure.All
		FDA has announced that it intends to initiate a rulemaking for dietary supplements for women who are or who may become pregnant.
		FDA has prohibited the importation of botanicals that are suspected to contain or be contaminated with aristolochic acid, unless firms can prove that their products are free of the toxic substance;
		FDA has issued warning letters to several firms informing them that their products are adulterated within the meaning of the Food, Drug, and Cosmetic Act, present a significant risk to consumer health, and should be immediately recalled from the marketplace; and
	www.ftc.gov /opa/2001/06/cureall.htm (3682 words)

	FDA
		The FDA appears to be unduly and, in our opinion, over-concerned about the safety of vitamins and herbs when the health hazards of these products do not even come close to the health risks and serious side-effects of prescription medication.
		This was the case when, in June 1997, FDA proposed, among other things, to limit the amount of ephedrine alkaloids in dietary supplements (marketed as ephedra, Ma huang, Chinese ephedra, and epitonin, for example) and provide warnings to consumers about hazards associated with use of dietary supplements containing the ingredients.
		FDA's proposal is consistent with the guidance on the distinction between structure-function and disease claims provided in the 1997 report by the President's Commission on Dietary Supplement Labels.
	www.nutritiondynamics.com /fda (4396 words)

	Le Magazine, May 2001 - Cover Story: What's Wrong With The Fda
		The greatest threat the FDA poses to our health is the fact that the agency functions as a roadblock to the development of breakthrough medical therapies.
		The Court ruled the FDAâs health claim standard to be arbitrary and capricious because it was so subjective that no one could determine precisely what level of scientific evidence FDA expected in order to approve a claim.
		FDA was supposed to implement the decision immediately, fully and faithfully.
	www.lef.org /magazine/mag2001/may2001_cover_pearson2_1.html (1222 words)

	FDA Alumni Association
		FDA: A Century Of Consumer Protection, commemorates the 100th anniversary of the enactment of the 1906 Pure Food and Drugs Act.
		The book includes a preface by the FDA Acting Commissioner, eleven major chapters covering all aspects of FDA during the last century, personal reminiscences by current and former FDAers, and photographs depicting the FDA story.
		The Association's core mission is to help alumni stay in touch with the issues of the day facing the FDA and support the agency's public health mission through expertise- and experience-sharing, training and outreach opportunities.
	www.fdaaa.org (1181 words)

	FDA
		These products are in compliance with the law and FDA regulations; noncompliance is identified and corrected; and any unsafe or unlawful products are removed from the marketplace.
		FDA principally serves the general public in its health and safety mission.
		FDA also recognizes its responsibilities to the industries that it regulates and will work with them in shepherding new technologies to the marketplace.Thus it strives to maximize public health protection while minimizing regulatory burden.
	www.biospace.com /b2/company_profile.cfm?CompanyID=1376 (402 words)

	Aspartame What You Don't Know Can Hurt You - FDA is not protecting you
		This study was submitted to the FDA after they had already approved aspartame for limited use.
		In their investigation, the FDA 1975 Task Force reviewed a study done for Searle in 1969 by Dr. Harry Waisman, Professor of Pediatrics at the University of Wisconsin.
		If the FDA had been really concerned, they should have insisted on reviewing all of the original research before it was approved for limited use in 1974.
	www.mercola.com /article/aspartame/fda.htm (1600 words)

	the FDA articles and information
		The FDA is asking the makers of popular antidepressant drugs to add suicide warnings to the labels of their drugs and to advise doctors to carefully monitor patients taking the pharmaceuticals.
		As the FDA moves towards its announcement as to the future of the cloned foods industry, the Consumer Federation of America remains unconvinced, citing a lack of sufficient evidence to prove the safety of cloned meat and milk.
		The FDA is holding on its approval of Agidermatics skin-cancer drug, but in the meantime the company is pouring research dollars into cosmeceuticals: A new line of drugs that supposedly enhance the appearance of youthfulness but aren't regulated by the FDA because they aren't considered drugs.
	www.newstarget.com /the_FDA.html (16883 words)

	Vioxx Shows: FDA Unable To Protect Public From Deadly Medical Drugs - Health Supreme
		The FDA is the national food and medicines regulatory agency of the US but it has been held in high esteem in countries world wide, where drug safety is the issue.
		In fact, the FDA reviewer went on to point out that ‘[w]ith the available data, it is impossible to answer with complete certainty whether the risk of cardiovascular and thromboembolic events is increased in patients on rofecoxib [Vioxx].
		FDA officials forget that they are public servants who have an appalling record on drug safety issues.
	www.newmediaexplorer.org /sepp/2004/11/23/vioxx_shows_fda_unable_to_protect_public_from_deadly_medical_drugs.htm (6597 words)

	FDA officials ordered herb books destroyed!!! (Site not responding. Last check: 2007-10-16)
		The FDA goes ballistic when it thinks a company is selling stevia as a natural sweetener - a property for which the herb is well-known in Paraguay and Brazil where it grows.
		According to FDA officials, the herb stevia can be "adulterated," merely by being in the presence of information that reveals its sweetening property.
		The FDA approves of them but not a sweetener (Stevia) that is far more sweeter than sugar and has no none side effects after years of use and is natural.
	www.california.com /~hawk/booksdestroyed.htm (2224 words)

	White House Defends FDA as Drug Safety Debate Looms (washingtonpost.com)
		Card made his comments about the FDA during ABC's "This Week," when he was asked whether he supported last week's call by Sen. Charles E. Grassley (R-Iowa), chairman of the Senate Finance Committee, for an investigation of the federal drug agency similar in scale to the Sept. 11 commission.
		According to FDA drug safety officer and whistle-blower David Graham, his research showing apparent dangers in Vioxx was suppressed by the agency.
		Grassley has called for FDA reforms that would enlarge the agency's Office of Drug Safety and make it more independent, but has acknowledged there is not strong support for the idea.
	www.washingtonpost.com /wp-dyn/articles/A11900-2004Dec19.html (970 words)

	Technorati Tag: FDA (Site not responding. Last check: 2007-10-16)
		The FDA has sent warning letters to makers of various cherry products advising them they are in serious violation of the Federal Food, Drug, and...
		Commissioner Lester Crawford, better known as the ex-commissioner of the FDA, is being a bad boy.
		In The Public Service Posted by Jason on October 14th, 2005 at 7:00 am When the FDA was considering allowing the morning-after contraceptive Plan B to...
	www.technorati.com /tag/FDA (590 words)

	HealthAction Action Center (Site not responding. Last check: 2007-10-16)
		Right now, the FDA is reviewing the New Dietary Ingredient clause in DSHEA and making new rules that may impact your health and access to safe and innovative dietary supplements.
		I urge you to ensure that any new FDA guidelines for New Dietary Ingredients reflect the intent of Congress and continue to provide complete access to the safe, affordable and innovative dietary supplements I rely on for my health.
		I applaud the FDA's initiatives to fully implement DSHEA and to develop clear guidelines for manufacturers to follow when introducing new ingredients to the market, but I'm concerned that the questions FDA poses in their draft comments may lead to barriers that may preclude many safe products from reaching the market place.
	www.healthactioncenter.com /action/index.asp?step=2&item=23589&ms=c4 (628 words)

	Bad News about products with Aspartame
		For over eight years the FDA refused to approve it because of the seizures and brain tumors this drug produced in lab animals.
		The FDA continued to refuse to approve it until President Reagan took office (a friend of Searle) and fired the FDA Commissioner who wouldn't approve it.
		Much worse, on 27 June 1996, without public notice, the FDA removed all restrictions from aspartame allowing it to be used in everything, including all heated and baked goods.
	www.dorway.com /badnews.html (1974 words)

	Fish Encyclopedia
		The FDA Seafood List is a searchable compendium of more than 1500 species of finfish and shellfish important in the U.S. It includes Approved Market Names, Common Names, Scientific Names, Vernacular (local) Names and links back to the RFE for those species included.
		It was developed by FDA's RFE Team to help federal, state, and local officials and purchasers of seafood identify species substitution and economic deception in the marketplace.
		Species selections made in conjunction with FDA Seafoods National Expert Jim Barnett of the Seattle District (Contact Jim Barnett at jbarnett@ora.fda.gov), and also in conjunction with the Office of Seafood, CFSAN.
	www.ovayonda.org /fishing/FDA-RFE.htm (704 words)

	4VeriChip.com (Site not responding. Last check: 2007-10-16)
		The FDA clearance follows the completion of a de novo application review.
		As previously disclosed, the FDA response is the result of the Company’s 510(k) application and subsequent de novo application for the medical and healthcare uses of VeriChip, originally submitted in October 2003.
		A small amount of radio frequency energy passes from the scanner energizing the dormant VeriChip, which then emits a radio frequency signal transmitting the verification number.
	www.4verichip.com /nws_10132004FDA.htm (704 words)

	Reputation of the FDA in shambles after Vioxx scandal; calls for wholesale FDA reform gain momentum
		The reputation of both the FDA and Merck lies in shambles today after evidence continues to surface that shows the FDA knowingly approved, promoted and refused to recall a dangerous drug that caused an untold number of fatalities among the American population: Vioxx.
		He also explained, "...with Vioxx, Merck and the FDA acted out of ruthless, short-sighted, and irresponsible self-interest." In other words, Merck and the FDA were playing the classic "cover your ass" game in trying to hide the destructive health consequences of Vioxx from the public for as long as possible.
		In a very real sense, the FDA is the godfather of the U.S. drug racket, where dangerous chemicals are hyped, approved and sold to the American people, regardless of their true dangers.
	www.newstarget.com /002157.html (1358 words)

	FDA News
		FDA News continually updated from thousands of sources around the net.
		FDA announces the use of new electronic drug labels to help better inform...
		FDA Decision On Exubera Not Expected For At Least 3 Months
	www.topix.net /us/fda (1193 words)

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