PhRMA makes nine recommendations for changes to an FDA draft guidance on the platform technology designation program.
Ali Pharmaceutical asks FDA to require AbbVie to stop saying it is using Alis Armour Thyroid in a clinical trial since it is using a biologic with a d...
Politico explores the many ideas people have for improving FDFA regulation of artificial intelligence.
FDA releases the form FDA-483 with five observations from an inspection at the Otsuka Pharmaceutical second factory in Tokushima, Japan.
FDA clears an Embecta 510(k) for its Disposable Patch Pump for Insulin Delivery, intended for use by adults who require insulin to manage diabetes.
Federal Register notice: FDA classifies neuromuscular tongue muscle stimulators and their use for reducing snoring and obstructive sleep apnea into Cl...
CDER and CBER seek input to help advance the agencys model-informed drug development program.
FDA grants an emergency use authorization for an updated version of Novavaxs Covid-19 vaccine that more closely targets currently circulating variants...
