FDA Special Protocol Assessment (SPA) For Expanded Indication Of LibiGel In FSD For Female Sexual Dysfuntion (Medical News Today)
BioSante Pharmaceuticals, Inc. (NASDAQ: BPAX) announced today that it successfully has completed and reached an additional agreement with the U.S.

FDA Grants Clearance For Celera's ViroSeq HIV-1 Genotyping System Software V2.8 (Medical News Today)
Celera (NASDAQ:CRA) announced that it has received marketing clearance from the U.S. Food and Drug Administration for its 510(k) submission of the ViroSeq HIV-1 Genotyping System Software v2.8. The ViroSeq HIV-1 Genotyping System is designed to detect mutations in the HIV-1 viral genome that confer drug resistance, and as such, is used as an aid in monitoring and treating HIV-1 infections.

Cloud over US FDA inspection (rediff.com)
Two US Congress members have expressed doubts over the quality of inspections conducted by the US Food and Drugs Administration (FDA) on Indian drug manufacturing facilities.