An FDA report says generic drug approvals in 2018-2020 led to billions of dollars in savings.
CDER representatives will participate in an In Vitro Pharmacology working group being assembled by Pistoia Alliance.
Congressional negotiations on FDA user fee reauthorization are continuing, with some major changes in play, according to Politico.
CDER Office of Compliance director Don Ashley tells a regulatory conference that the Center is planning a guidance document on the modernization of cl...
FDA denies a Braintree citizen petition that asked it not to approve a tablet-based or tablet-containing colonoscopy preparation unless it contains a ...
Federal Register notice: FDA makes available a final guidance entitled Policy for Monkeypox Tests To Address the Public Health Emergency.
Federal Register notice: FDA announces an 11/18 joint advisory committee meeting to discuss a Laboratoire HRA Pharma supplemental NDA for Opill (norge...
Federal Register notice: FDA finalizes a list of alternative or streamlined mechanisms for complying with GMP requirements for combination products.
