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CDRH seeks a boost to its resources as it negotiates the reauthorization of the Medical Device User Fee Act (MDUFA) program, claim...[ Price : $8.95]
The Justice Department asks a California federal court for an injunction to prevent Med-Pharmx from manufacturing and distributing...[ Price : $8.95]
FDA issues a guidance on nonclinical information to support the development and approval of orally inhaled nicotine-containing dru...[ Price : $8.95]
Four drug companies recommend technical changes to an FDA draft guidance on evaluating cancer drugs in patients with central nervo...[ Price : $8.95]
Federal Register notice: FDA makes available a final guidance entitled Necessary Automated External Defibrillator Accessories: Pol...[ Price : $8.95]
Federal Register Notice: FDA makes available a final guidance on how to reference Approved drug products in ANDA submissions.[ Price : $8.95]
FDA releases a meeting summary with recommendations on artificial intelligence and machine learning from the Patient Engagement Ad...[ Price : $8.95]
CDER publishes a MAPP on responsibilities and procedures for developing two types of REMS.