The Food and Drug Administration should rethink its rejection of the Declaration of Helsinki. Later this year, the US Food and Drug Administration (FDA) will adopt new standards for human clinical trials conducted without its advance sign-off in foreign countries. The rules will govern whether data from such trials can be used in applications to [...]
Inconvenient Woman readers know that I’m not an FDA fan. In my opinion, the troubled agency’s close ties and financial dependence on Big Pharma has been weakened its ability to perform its primary function — protecting the public. The FDA’s documented failure to impartially judge the veracity of drug trial results and enforce safety oversight [...]
Analysis of decades of drug approvals by a Harvard Research team, published in the March 27th New England Journal of Medicine, provides the first scientific evidence of what many have come to suspect. Congress-mandated deadlines that control the FDA review of new medications may have “spurred a dangerous rush to judgment.” Looking at drugs that [...]
FDA News FOR IMMEDIATE RELEASE March 27, 2008 Media Inquiries: Chris DiFrancesco, 301-827-6242 Consumer Inquiries: 888-INFO-FDA FDA Identifies First Steps in Requirements for Safety Plans for Certain Drugs and Biologics New FDAAA requirements being implemented The U.S. Food and Drug Administration has identified 25 drugs and biologic products that will be required to submit safety [...]
FDA has granted priority review status to Merck’s application to expand marketing of its human papillomavirus vaccine Gardasil to women ages 27 to 45, the company said Wednesday, Reuters reports. The designation means that an FDA decision could come within six months, according to Reuters. currently is approved by the FDA for use by girls [...]
Glaxo, still struggling to overcome the Avandia diabetes pill controversy and subsequent lost revenue, has been dealt another blow by the FDA. The agency has issued a “complete response letter” to Glaxo for its Cervarix vaccine. It is unclear whether the FDA will require additional clinical trials for Cervarix. The unexpected delay in approval could last as little as six-months or as long as two-years.
Merck recently has been providing lobbyists throughout the country with information about its human papillomavirus vaccine Gardasil in an effort to encourage states to mandate that middle-school age girls receive it, the Baltimore Sun reports (Smitherman, Baltimore Sun, 1/29). FDA in July 2006 approved Gardasil for sale and marketing to girls and women ages nine [...]
The Food and Drug Administration (FDA) today announced the approval of Gardasil, the first vaccine developed to prevent cervical cancer, precancerous genital lesions and genital warts due to human papillomavirus (HPV) types 6, 11, 16 and 18. The vaccine is approved for use in females 9-26 years of age. Gardasil was evaluated and approved in six months under FDA’s priority review process–a process for products with potential to provide significant health benefits.
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