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Woodcock Updates Senate on Budget Request

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Acting FDA commissioner Janet Woodcock describes FDAs current priorities at a Senate appropriations hearing on budget priorities, ...

2 Advisory Panel Members Resign Over Alzheimers Approval

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Two members of the advisory committee that reviewed data and voted against approving Biogens Alzheimers therapy resign in protest ...

4 Observations in BSO Inspection

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FDA releases an FDA-483 with four observations from an inspection at the BSO outsourcing facility.

Info Collection: Investigational Use Animal Drugs

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Federal Register notice: FDA sends to OMB an information collection extension for New Animal Drugs for Investigational Use 21 CFR...

FDA, Acer Agree on Edsivo Pivotal Clinical Trial

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Acer Therapeutics plans to submit an IND and protocol for a pivotal study of its Edsivo to treat patients with COL3A1+ vascular Eh...

Notice on CDISC eSubmission Standards Corrected

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Federal Register notice: FDA corrects a document that appeared in the 3/11/2020 Federal Register that announced the agency will be...

FDA OKs Medtronic Vanta

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FDA approves Medtronics Vanta recharge-free implantable neurostimulator.

FDA Cites 2 Minn. Clinical Investigators

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FDA releases the FDA-483 issued following 2019 inspections of two trial investigators at the Hennepin County Medical Center.

Info Collection Extension for Drug GMPs

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Federal Register notice: FDA sends to OMB an information collection extension on GMPs for finished pharmaceuticals and active phar...

Medical Imaging Drugs Panel Renewed for 2 Years

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Federal Register notice: FDA renews its Medical Imaging Drugs Advisory Committee for an additional two years.