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FDA Hold on Celyad Oncology Trial

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FDA puts a clinical hold on a Ceylad Oncology Phase 1b trial due to insufficient information to assess the risk to study subjects.

Former FDAer Wants Freeze on Russian Applications

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Former FDAer Timothy Cote asks FDA to suspend regulatory actions on all requests it has from Russian pharmaceutical and medical de...

FDA-483 from OSRX Inspection

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FDA releases the FDA-483 with one observation issued following an inspection at OSRX, a Missoula, MT, sterile drug compounder.

2nd Patient-Focused Drug Development Guidance

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

Bone Fixation Screw Sleeve Class 2

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

Guidance on CDRHs Appeals Processes

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

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

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Pink Concussions asks FDA to revoke clearance for the SyncThink Eye-Sync as an aid in diagnosing concussions because it does not a...

FDA Still Not Releasing Drug NCT Numbers

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

Stakeholder Comments on Real-World Data Guidance

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Three stakeholders comment on an FDA draft guidance on using registries to support drug and biological product regulatory decision...

3 FDA Guidances Support Cancer Moonshot: Pazdur

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