The Informed Consent Action Network says FDA should withdraw approval of the IPOL polio vaccine until adequate clinical trials demonstrate its safety.
FDA denies a citizen petition seeking a freeze on all regulatory requests from pharmaceutical and medical device companies headquartered in Russia or ...
FDA clears a Surgalign Holdings 510(k) for its Cortera Spinal Fixation System.
Federal Register notice: FDA makes available a revised draft guidance for industry entitled Charging for Investigational Drugs Under an IND: Questions...
Federal Register notice: FDA announces an 11/2-3 Pharmaceutical Science and Clinical Pharmacology Advisory Committee meeting to discuss CDERs Quality ...
GlaxoSmithKline asks the Supreme Court not to hear Tevas appeal of a federal appeals court decision in a case involving a so-called skinny label for t...
Two stakeholders raise questions about an FDA draft guidance on risk management plans to mitigate drug shortages.
Morton Grove Pharmaceuticals decides to close its business as part of a federal court-approved consent decree of permanent injunction over adulterated...
