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Federal Register notice: FDA makes available a draft guidance entitled Principles of Premarket Pathways for Combination Products that discusses how to...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.
A new report on citizen petitions seeking to delay or prevent a drug/biosimilar approval finds that only one product was delayed approval due to such ...
Stakeholders ask for additional work on an FDA updated final guidance on good review management principles and practices.
CDER issues a MAPP on responsibilities and procedures for developing some REMS.