PhRMA makes nine recommendations for changes to an FDA draft guidance on the platform technology designation program.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.
CDER reports on research into how healthcare providers view and use Boxed Warnings when making treatment decisions for their patients.
Denali Therapeutics plans to submit a BLA early next year that will seek accelerated approval for DNL310 (tividenofusp alfa) and its use in treating H...
FDA releases a guidance entitled Bioresearch Monitoring Technical Conformance Guide Technical Specifications Document that provides current agency sp...
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.
