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FDA FY 21 Budget Initiatives Analyzed

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The Alliance for a Stronger FDA lists six programs likely to get additional funding from the FY 21 agency budget.

License for Mass Spectrometry for Covid, Other Uses

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Federal Register notice: FDA contemplates the grant of an exclusive patent license to Advion, Inc. (Ithaca, NY) for a government-o...

Safety Labeling Change Posted for Ocrevus

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FDA posts a safety labeling change for Genentechs Ocrevus.

FDA Conditions Lilly EUA with GMP Requirements

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FDA places GMP-related conditions on its recent emergency use authorization for Eli Lillys investigational monoclonal antibody the...

FDA Researching Return of Drug Manufacturing to U.S.

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FDA contracts with the University of Maryland Smith School of Business to research the possibility of increasing drug manufacturin...

CVM Documenting Electronic Data File Guidance

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FDA issues a guidance with recommendations for documenting electronic data files and statistical analyses submitted to CVM to supp...

SafKan Impacted Earwax Device Cleared

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FDA clears a SafKan Health 510(k) for its OtoSet Ear Cleaning System for removing impacted earwax.

Summary of Panel VisAbility System Discussion

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FDA releases the summary of an Ophthalmic Devices Panel meeting that recommended against approving the Refocus Groups VisAbility M...

Cook Fixed Core Wire Guide Recall Class 1

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FDA says a Cook Medical recall of its fixed core wire guides is Class 1.

Hahn Said to be On Thin Ice Over Pfizer Vaccine News

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The Washington Post suggests FDA commissioner Stephen Hahns job hangs in the balance due to president Trumps anger over promising ...