Stakeholders praise an FDA draft guidance on use of minimal residual disease as a biomarker in developing drugs to treat blood cancers.
Federal Register notice: FDA makes available a final guidance entitled Questions and Answers on Biosimilar Development and the BPCI Act.
Federal Register notice: FDA announces the availability of a final guidance entitled Interpretation of the Deemed To Be a License Provision of the Bio...
Federal Register notice: FDA announces the availability of a draft guidance entitled The Deemed to be a License Provision of the BPCI Act: Questions a...
FDA issues a question-and-answer guidance on data integrity and compliance with drug CGMPs.
FDA issues a guidance explaining user fees and refunds for PMAs and some device BLAs as outlined in the MDUFA 4 agreement.
FDA cautions consumers that two HelloCig e-liquids illegally contain undeclared prescription drug active ingredients used to treat erectile dysfunctio...
Three Fried Frank attorneys say the Justice Department must allow discovery on False Claims Act questions of materiality if the government wants the f...