BioSante Pharmaceuticals Announces FDA Special Protocol Assessment (SPA) for LibiGel(R) in FSD (Centre Daily Times)
BioSante Pharmaceuticals, Inc. (NASDAQ: BPAX) announced today that it successfully has completed and reached agreement with the U.S. Food and Drug Administration (FDA) under the Special Protocol Assessment (SPA) process for its Phase III safety and efficacy clinical trials for LibiGel (transdermal testosterone gel) in the treatment of female sexual dysfunction (FSD), specifically, hypoactive ...

FDA warns Novartis over vaccine sterility (Reuters via Yahoo! News)
U.S. regulators warned Novartis AG that a German plant has produced contaminated vaccines, and it has failed to track down the source of the problems, a letter released on Tuesday said.

HiFi DNA Tech Questions FDA In Lawsuit - 'Why HPV DNA PCR Is Acceptable For Gardasil(R) Approval, But Not Acceptable ... (Medical News Today)
HiFi DNA Tech has filed suit against the U.S. Food and Drug Administration here in U.S. Federal District Court requesting the high court overturn the FDA's denial of HiFi's petition for reclassification of its human papillomavirus (HPV) DNA detection device from the more-restrictive class III to class II.