FDA publishes the second in a planned series of four methodological guidances on patient-focused drug development.
Federal Register notice: FDA classifies the screw sleeve bone fixation device into Class 2.
FDA releases final guidance on CDRHs Appeals Processes that describes the processes available to stakeholders to seek supervisory review of decisions ...
Pink Concussions asks FDA to revoke clearance for the SyncThink Eye-Sync as an aid in diagnosing concussions because it does not add any value to a sy...
Attorney and data scientist Bradley Thompson says FDA hasnt responded to his request for information on when it will start releasing NCT numbers assoc...
Three stakeholders comment on an FDA draft guidance on using registries to support drug and biological product regulatory decision-making as part of r...
FDA releases three final cancer clinical trial guidances that officials say track with President Bidens renewed Cancer Moonshot.
FDA issues Gilead Sciences a complete response letter on its NDA for lenacapavir, an investigational, long-acting HIV-1 capsid inhibitor for treating ...