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 … [Read more...] about The FDA Fails To Protect Patient Rights
FDA Approvals
A Guide to Drug Safety Terms at FDA
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 … [Read more...] about A Guide to Drug Safety Terms at FDA
Deadlines May Affect FDA Decision Process
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 … [Read more...] about Deadlines May Affect FDA Decision Process
FDA Identifies First Steps in Requirements for Safety Plans
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 … [Read more...] about FDA Identifies First Steps in Requirements for Safety Plans
FDA To Review Merck’s Application To Expand HPV Vaccine Gardasil’s Approval To Older Women
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 … [Read more...] about FDA To Review Merck’s Application To Expand HPV Vaccine Gardasil’s Approval To Older Women