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FDA Conditions Lilly EUA with GMP Requirements

[ Price : $8.95]

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 ...

MAPP on Reviewing DEA Research Protocols

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FDA issues a MAPP on responsibilities and procedures for the CDER controlled substances staff to review and comment on DEA researc...

Scholars Question FDA Drug Importation Rule: Report

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A University of Pennsylvania Law School regulatory analysis examines a Council on Foreign Relations working paper critiquing the n...

ICAN Wants Tougher Covid Vaccine Efficacy Standards

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The Informed Consent Action Network asks FDA to order changes to the Phase 3 trial protocols for four Covid-19 vaccines that it sa...