FDA approves an Orthofix Medical PMA for the M6-C artificial cervical disc for patients suffering from cervical disc degeneration.
FDA approves a Perrigo ANDA for a generic copy of GlaxoSmithKlines Zovirax Cream, 5% (acyclovir cream).
FDA releases a guidance entitled Intent to Exempt Certain Unclassified Medical Devices from Premarket Notification Requirements.
Federal Register notice: FDA posts a final guidance entitled Opioid Use Disorder: Developing Depot Buprenorphine Products for Treatment.
Federal Register notice: FDA announces the start of a pilot program under the Drug Supply Chain Security Act.
Johnson & Johnson pharmaceutical group Janssen becomes the first drug company to agree to begin including list price information in drug direct-to-con...
Federal Register notice: FDA makes available a draft guidance entitled Principles of Premarket Pathways for Combination Products that discusses how to...
FDA issues a final guidance on drug company public warnings about voluntary recalls.