FDA releases its latest batch of Warning Letters that include Actavis Laboratories, AndaPharm, New Era Naturals and Vilvet Pharmaceuticals.
One month shy of his second full year in the job, FDA commissioner Scott Gottlieb resigns to spend more time with his family in Connecticut.
FDA solicits comments on a proposal to limit some flow cytometer instruments from premarket notification requirements.
FDA agrees to accept a CytoDyn rolling BLA submission for PRO 140 (leronlimab), a CCR5 antagonist, indicated for blocking HIV-1 from entering and infe...
Federal Register notice: FDA makes available a final guidance entitled Evaluation of Bulk Drug Substances Nominated for Use in Compounding Under Secti...
Federal Register notice: FDA identifies two bulk drug substances that it has considered and is not including on its drug compounding bulk drug substan...
FDA sends Evoke Pharma a multi-disciplinary review letter on its 505(b)(2) NDA for Gimoti (metoclopramide), a nasal spray indicated for treating gastr...
Intellipharmaceutics International resubmits an NDA for its oxycodone ER product candidate, indicated for treating pain.