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Human Drugs

EUA for Mercks Molnupiravir Covid Treatment

FDA issues an emergency use authorization for Mercks molnupiravir to treat mild-to-moderate Covid-19 in some adults.

Human Drugs

Padagis Recalls Nitroglycerin Spray

Padagis recalls three lots of 12 g spray bottles of nitroglycerin lingual spray labeled for Perrigo due to the potential for a defective dispenser.

Human Drugs

EUA for Pfizer Paxlovid Covid Pill

FDA grants an emergency use authorization for Pfizers Paxlovid, the first oral treatment for some Covid-19 cases.

Federal Register

Federal Register Notices 12/20-12/30

FDA Review posts the following Federal Register notices that published during our annual holiday break (12/20-12/30).

FDA General

Product Approval Summaries

FDA Review posts product approval summaries for the week ending 12/31/2021.

Human Drugs

Since Our Last Issue ...

Industry news you may have missed since our last issue.

Medical Devices

Baxter Volara System Recall is Class 1

FDA says the Baxter Healthcare recall of its Volara system due to risk of respiratory distress in home use is Class 1.

Explain Need for Trial Diversity: Caplan

New York University bioethicist Arthur Caplan says those calling for greater diversity in clinical trials should clearly explain the benefits of such ...

Federal Register

Nominations Sought for Device Panels

Federal Register notice: FDA seeks nominations for voting members to serve on CDRHs Medical Devices Advisory Committee device panels.

Medical Devices

FDA Mulls 510(k) Sterilization Master File

FDA says it is considering an additional Sterilization Master File Pilot Program for sterilization changes to 510(k) cleared medical devices.