FDA posts a final guidance on Requesting FDA Feedback on Combination Products.
Federal Register notice: FDA seeks comments on an information collection extension for Formal Dispute Resolution: Scientific and Technical Issues Rela...
FDA advisory committee briefing information confirms 95% efficacy with Pfizer-BioNTechs Covid-19 vaccine.
FDA clears a Zebra Medical Vision 510(k) for its artificial intelligence analytics that extract bone measurements from X-ray scans for planning orthop...
FDA publishes the FDA-483 with six inspection observations issued to Juno Therapeutics.
FDA issues guidances with recommended best practices to use in developing proprietary names for human prescription and non-prescription drugs.
The ACLU says federal courts should continue to block an FDA policy requiring patients seeking mifepristone to appear in person at a health center to ...
FDA says the Oncology Center of Excellences Project Orbis received 60 applications in its first full year of existence and approved 38 new drugs and n...