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.
FDA publishes a draft guidance entitled Computer Software Assurance for Production and Quality System Software that the agency says offers a risk-base...
FDA approves a Bristol Myers Squibb NDA for plaque psoriasis drug Sotyktu (deucravacitinib), a first-in-class, oral, selective, allosteric tyrosine ki...
BioMarin Pharmaceutical tells FDA a patient participating in the companys hemophilia A Phase 3 gene therapy trial of valoctocogene roxaparvovec (BMN 2...
