FDA lifts its clinical hold against a MaaT Pharma IND for an open-label, single arm Phase 3 pivotal clinical trial evaluating the safety and efficacy ...
Senate HELP Committee leaders reach a legislative bipartisan deal to expand the availability of low-cost generic drugs, clarify orphan drug exclusivit...
Federal Register notice: FDA seeks comments on an information collection extension entitled Customer/Partner Service Satisfaction Surveys.
FDA sends a letter to Sun Pharma telling the company that it is out of compliance with a 2012 consent decree after an inspection last year at the comp...
FDA warns Alexandria, Egypt-based Pharmaplast about CGMP violations in its manufacturing of finished drugs.
In two suits, Florida says FDA is violating the Freedom of Information Act by not responding to the states request for information on its application ...
The U.S. Supreme Court grants FDA a temporary win by ordering a stay of a lower courts order to restrict the distribution of the abortion drug mifepri...
CDERs Office of Prescription Drug Promotion discusses a survey to better understand quantitative claims in direct-to-consumer prescription drug advert...
