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Human Drugs

2nd Patient-Focused Drug Development Guidance

FDA publishes the second in a planned series of four methodological guidances on patient-focused drug development.

Federal Register

Bone Fixation Screw Sleeve Class 2

Federal Register notice: FDA classifies the screw sleeve bone fixation device into Class 2.

Medical Devices

Guidance on CDRHs Appeals Processes

FDA releases final guidance on CDRHs Appeals Processes that describes the processes available to stakeholders to seek supervisory review of decisions ...

Medical Devices

Revoke Eye-Sync 510(k) Indication: Pink Concussions

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...

FDA Still Not Releasing Drug NCT Numbers

Attorney and data scientist Bradley Thompson says FDA hasnt responded to his request for information on when it will start releasing NCT numbers assoc...

Human Drugs

Stakeholder Comments on Real-World Data Guidance

Three stakeholders comment on an FDA draft guidance on using registries to support drug and biological product regulatory decision-making as part of r...

Human Drugs

3 FDA Guidances Support Cancer Moonshot: Pazdur

FDA releases three final cancer clinical trial guidances that officials say track with President Bidens renewed Cancer Moonshot.

Human Drugs

Gilead HIV Drug Gets Complete Response Letter

FDA issues Gilead Sciences a complete response letter on its NDA for lenacapavir, an investigational, long-acting HIV-1 capsid inhibitor for treating ...

Medical Devices

FDA Warns on 3 Covid-19 Tests

FDA issues three safety alerts warning users to not use three Covid-19 tests because they could generate false results.

Federal Register

Guide on Patient-Focused Drug Development

Federal Register notice: FDA makes available a final guidance entitled Patient-Focused Drug Development: Methods To Identify What Is Important to Pati...