Five stakeholders raise concerns about an FDA draft guidance on when a new 510(k) should be submitted for a change to an existing medical device.
In its latest batch of Warning Letters, FDA cites Innovative Compounding Pharmacy and Valeant Pharmaceuticals.
Federal Register Final Rule: FDA issues a final rule to amend the regulations to reflect organization change in the agency and to make other conformin...
Federal Register Notice: FDA establishes a public docket to collect comments related to a proposed Study Data Standardization Plan template.
FDA places a clinical hold on a BioInvent International Phase 2 study of the antibody BI-505 in patients with multiple myeloma.
FDA posts a guidance on Non-Inferiority Clinical Trials to Establish Effectiveness that discusses the appropriate use of such study designs to provide...
FDA considers industry and advertiser proposals to allow links to risk information for promotional activities on character space-limited social media ...
Federal Register Notice: FDA asks for comments on an OMB submission seeking an information collection extension on the use of focus groups about drug ...