[ Price : $8.95]
FDA posts a draft guidance entitled Unique Device Identifier (UDI) Requirements for Combination Products.[ Price : $8.95]
Former CBER director Peter Marks says FDA should explain why it changed its Covid-19 vaccine policy in a way that did not promote ...[ Price : $8.95]
FDA publishes a guidance with questions and answers on its various remote regulatory assessment tools.[ Price : $8.95]
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.