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Curis Lymphoma Study on Partial Hold

[ Price : $8.95]

FDA places a partial clinical hold on Curis TakeAim Lymphoma study a of emavusertib in patients with B-cell malignancies.

Should Food Finally be Removed from FDA Oversight?

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A new Politico investigation details FDAs mishandling of food safety oversight, which may draw renewed interest from Capitol Hill ...

FDA Alert on Vessel Occlusion CADt Devices

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FDA reminds healthcare providers that radiological computer-aided triage and notification devices for intracranial large vessel oc...

Vanda Sues FDA Over Drug Review Documents

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Vanda Pharmaceuticals files a lawsuit to compel FDA to produce drug review records associated with the companys supplemental NDA f...

Clinical Hold Lifted on Gileads Magrolimab

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FDA lifts a Gilead Sciences partial clinical hold on studies evaluating its investigational agent magrolimab in combination with a...

Latest Federal Register Notices

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FDA Review posts the latest Federal Register notices for the week ending 4/8/2022.

2 Device Guides on Performance Criteria

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Federal Register notice: FDA makes available two medical device guidance documents for the Safety and Performance Based Pathway.

Final Guide on ICH Drug Study Considerations

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Federal Register notice: FDA makes available a final guidance entitled E8(R1) General Considerations for Clinical Studies.

Pediatric Oncology Meeting on Study Waivers

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Federal Register notice: FDA announces a 5/11-12 Pediatric Oncology Subcommittee meeting to discuss FDA decisions on sponsor plans...

Medtronic MiniMed Recall Due to Labeling Design

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Medtronic recalls certain MiniMed 630G insulin pumps with SmartGuard due to a labeling design error that could cause the devices t...