FDA commissioner Scott Gottlieb tells a House FDA Appropriations Subcommittee hearing that the Trump Administrations January-ordered hiring freeze at ...
Federal Register notice: FDA posts a list of information collections that have been approved by the Office of Management and Budget.
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.
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.