Federal Register notice: FDA makes available a final guidance entitled S5(R3) Detection of Reproductive and Developmental Toxicity for Human Pharmaceu...
FDA says the Medtronic recall of its HeartWare HVAD system to update instructions for use and the patient manual due to three issues is Class 1.
FDA approves a Johnson & Johnson Vision PMA for its Acuvue Abiliti Overnight Therapeutic Lenses, the first orthokeratology contact lens for managing m...
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.