FDA acting commissioner Janet Woodcock says there continues to be huge opportunities for growth in the generic and biosimilar space.
FDA approves an Eton Pharmaceuticals and Azurity Pharmaceuticals NDA for Eprontia (topiramate) oral solution, 25mg/mL, indicated as a monotherapy for ...
FDA clears a Magstim 510(k) for the Horizon 3.0, a transcranial magnetic stimulation device designed for the clinical setting.
FDA Review posts product approval summaries for the week ending 11/5/2021.
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.