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CVM Documenting Electronic Data File Guidance

[ Price : $8.95]

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

SafKan Impacted Earwax Device Cleared

[ Price : $8.95]

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

Summary of Panel VisAbility System Discussion

[ Price : $8.95]

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

[ Price : $8.95]

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

[ Price : $8.95]

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

[ Price : $8.95]

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

[ Price : $8.95]

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

[ Price : $8.95]

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

Hahn Outlines Covid, Other Agency Successes

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FDA commissioner Stephen Hahn says the agency is meeting many of its FY 2020 goals in addition to all of its Covid-19 work.

Beyond Air Submits PMA for LungFit PH

[ Price : $8.95]

Beyond Air says it submitted a PMA application to FDA for its LungFit PH to treat persistent pulmonary hypertension of the newborn...