Federal Register notice: FDA seeks comments on an information collection extension on Adverse Event Program for Medical Devices.
Federal Register notice: FDA seeks comments on an information collection Application for FDA Approval To Market a New Drug.
FDA completes three inspections this month at contract research organization BioPharma Services without issuing any Form 483s.
Anti-morcellation pioneer Amy Reed dies of her cancer.
FDA tells Sun Pharma its Elepsia XR NDA cannot be approved until inspection deficiencies at the firms Halol facility are resolved.
An FDA small business assistance podcast gives steps involved in meeting the requirement to electronically submit master files and associated document...
Sixty-five House members urge FDA to rescind a guidance banning physician office-use drug compounding.
The FDA Oncologic Drugs Advisory Committee votes to recommend to the agency that the risk/benefit profile for Emmaus sickle cell disease drug Endari i...