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Federal Register notice: FDA renews the charter of its Pharmaceutical Science and Clinical Pharmacology Advisory Committee for an ...[ Price : $8.95]
Federal Register notice: FDA makes available a final guidance entitled Providing Submissions in Electronic Format Postmarketing S...[ Price : $8.95]
The Medical Device Innovation Consortium publishes its framework on external evidence methods for medical devices based on input f...[ Price : $8.95]
Simulations Plus completes an FDA-funded project for a model-integrated design for bioequivalence studies in long-acting injectabl...[ Price : $8.95]
FDA commissioner Robert Califf says the agency is considering asking Congress for additional authority to have the option of requi...[ Price : $8.95]
The Biotechnology Innovation Organization suggests ways for FDA to create a conceptual framework to inform decision-making for ped...[ Price : $8.95]
Moderna is asking FDA for an emergency use authorization for its Covid-19 vaccine in children aged 6 months to 6 years old.[ Price : $8.95]
Lilly says its investigational weight-loss drug tirzepatide met all endpoints in the 72-week SURMOUNT-1 trial.