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Federal Register notice: FDA makes available a final guidance entitled Principles of Premarket Pathways for Combination Products....[ Price : $8.95]
Federal Register notice: FDA renews for an additional two years its Vaccines and Related Biological Products Advisory Committee.[ Price : $8.95]
FDA issues sterile drug product maker Johnson Memorial Cancer Center a Form FDA-483 after a 10/2021 inspection cited GMP deficienc...[ Price : $8.95]
A just-released CDRH annual report says it was able to grant marketing authorizations for 103 novel devices last year, despite bei...[ Price : $8.95]
FDA commissioner nominee Robert Califf agrees to significant ethics commitments in a move to secure Senate support for his nominat...[ Price : $8.95]
FDA grants full approval to Modernas Covid-19 vaccine under the name Spikevax for use in individuals 18 years of age and older.[ Price : $8.95]
Novavax has submitted an emergency use authorization for NVX-CoV2373, its protein-based Covid-19 vaccine candidate for adults 18 y...[ Price : $8.95]
Federal Register notice: FDA extends the comment period for a 12/23 notice on a draft guidance entitled Assessing the Credibility ...