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.
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.
Novartis files a Lanham Act suit against Janssen seeking to stop it from making false and misleading claims associated with Janssens Tremfya, indicate...
Former Insys Therapeutics sales vice president Alec Burlakoff testifies in Boston federal court on how he followed orders to recruit physicians and pa...