FDA issues Avidity Biosciences a partial clinical hold on new participant enrollment in its Phase 1/2 MARINA clinical trial of AOC 100 in adults with ...
Two stakeholders give FDA technical comments on a guidance based on an International Council for Harmonization guideline on drug interaction studies.
FDA publishes a guidance on 510(k) submissions for computer-assisted detection devices applied to radiology images and device data.
FDA issues a revised final guidance entitled Clinical Performance Assessment: Considerations for Computer-Assisted Detection Devices Applied to Radiol...
FDA releases the form FDA-483 with five observations from an inspection at the Ripley, MS-based Delta Pharma outsourcing facility.
Five stakeholders raise substantive concerns about an FDA draft guidance on selecting, developing, or modifying fit-for-purpose clinical outcomes asse...
FDA publishes a draft guidance on the required electronic format for submission of over-the-counter monographs.
FDA updates its Covid-19 test policy to send more tests through the traditional review pathways and away from emergency use authorizations.
