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
FDA Clinical Trials
There is A New Book in the Iconic Woman Bookshelf…
The Secret History of the War on Cancer By Devra Davis, PhD, MPH Review by Leslie Botha, Holy Hormones Honey! In a recent interview on CSPAN Davis stated, “For much of its history, the cancer war has been fighting the wrong battles, with the wrong weapons, against the … [Read more...] about There is A New Book in the Iconic Woman Bookshelf…
Vytorin — Another FDA Failure To Protect Public
Big Pharma Giants Schering and Merck Take Heavy Criticism Over Vytorin Failure This week Merck executives are very grateful for the revenue predictions for their blockbuster HPV vaccine, GARDASIL. Profits are predicted to climb from $300 million to $4 billion over the next … [Read more...] about Vytorin — Another FDA Failure To Protect Public
Who is Bankrolling the FDA and Why?
There has been no increase in congressional appropriations to the FDA from fiscal years 1986 through 2006. (1) FDA's Mission Statement The FDA is responsible for protecting the public health by assuring the safety, efficacy, and security of human and veterinary drugs, … [Read more...] about Who is Bankrolling the FDA and Why?
FDA Announces New Initiative to Modernize the Regulation of Clinical Trials
FDA Announces New Initiative to Modernize the Regulation of Clinical Trials and Bioresearch Monitoring The Food and Drug Administration (FDA) today announced a series of new policy and regulatory developments to strengthen the Agency's oversight and protection of patients in … [Read more...] about FDA Announces New Initiative to Modernize the Regulation of Clinical Trials