The American Society of Clinical Oncology and the Friends of Cancer Research jointly give FDA draft guidance language to expand eligibility for cancer...
FDA says it wants to do research on how well healthcare professionals and consumers can use direct-to-consumer print ad prescription drug disclosures ...
FDA extends to 9/24/19 the compliance date for submission requirements of a device constituent of co-packaged combination products assigned to CDER fo...
FDA announces a 9/10 public workshop entitled Human Dermal (Skin) Safety Testing for Topical Drug Products: Regulatory Utility and Evaluation.
FDA clears an Aidoc artificial intelligence solution for radiologists to flag acute intracranial hemorrhage cases in head computed tomography scans.
FDA issues a not approvable letter to PneumRx for its PMA application for Elevair Endobronchial Coil System for treating people with severe emphysema....
The FDA Antimicrobial Drug Advisory Committee tells the agency that Parateks omadacycline is safe and effective for two indications.
Federal Register notice: FDA withdraws approval of four NDAs from multiple applicants after they told the agency that the products were no longer mark...