FDA clears a Desktop Health 510(k) for its Flexcera Base, a proprietary resin for use in 3D fabrication of dental prosthetics.
Federal Register notice: FDA makes available a final guidance entitled Q12 Technical and Regulatory Considerations for Pharmaceutical Product Lifecycl...
FDA publishes an International Council for Harmonization guidance on the Biopharmaceutics Classification System-based biowaivers.
Federal Register notice: FDA withdraws approval of 12 ANDAs from multiple applicants after they notified the agency in writing that the drug products ...
Federal Register notice: FDA makes available a final guidance entitled Qualified Infectious Disease Product Designation Questions and Answers.
Federal Register notice: FDA makes available a final guidance entitled Covid-19: Developing Drugs and Biological Products for Treatment or Prevention....
Rocket Pharmaceuticals says FDA asked it to pause patient dosing and modify the protocol for its Phase 1 trial of RP-A501 to treat Danon Disease.
FDA says Anytime Covid Test is marketing and distributing unapproved, adulterated, and misbranded Covid-19 tests for home use.