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FDA posts a final guidance entitled Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submi...[ Price : $8.95]
FDA grants regenerative medicine advanced therapy designation for enGene Holdings bladder cancer drug detalimogene.[ Price : $8.95]
Viatris plans to submit an NDA later this year for phentolamine ophthalmic solution 0.75% for treating presbyopia based on just-re...[ Price : $8.95]
FDA warns Sterling Distributors about its multiple violations of the Drug Supply Chain Security Act.[ Price : $8.95]
FDA posts a final guidance entitled Early Lyme Disease as Manifested by Erythema Migrans: Developing Drugs for Treatment.[ Price : $8.95]
FDA approves an updated label for Eli Lillys Amyvid (florbetapir F 18 injection) for brain imaging to estimate amyloid plaque dens...[ Price : $8.95]
FDA requires and approves updates to the prescribing information for Pfizers Comirnaty Covid-19 mRNA vaccine and Modernas Spikevax...[ Price : $8.95]
A Global Biodefense online post says FDAs sudden decision to halt clinical trials that send samples overseas for processing can hu...