Federal Register notice: FDA sends to OMB an information collection revision for a guidance entitled Postmarketing Adverse Experience Reporting and Re...
Federal Register notice: FDA amends the animal drug regulations to reflect recent application-related actions for new animal drug applications and abb...
FDA issues a seven-item Form FDA-483 to ACRX Specialty (Las Vegas, NV) after finding GMP problems during an inspection in July.
Promising new data on its investigational Covid-19 oral antiviral agent Paxlovid PF prompts Pfizer to plan its early submission to the ongoing rolling...
FDA grants ReWalk Robotics a breakthrough device designation for its ReBoot, an exo-suit intended to assist ambulatory functions in individuals with r...
An FDA advisory committee votes 12 to 1 that a Levo Therapeutics NDA for carbetocin nasal spray and its use for treating Prader-Willi syndrome did not...
FDA approves a Tris Pharma NDA for Dyanavel XR (amphetamine), extended release once-daily tablets for treating attention-deficit hyperactivity disorde...
Federal Register notice: FDA makes available a final guidance entitled Manufacture of Blood Components Using a Pathogen Reduction Device in Blood Esta...