FDA Related News

Federal Register

Pfizer Wins Priority Review Voucher for Paxlovid

Federal Register notice: FDA issues a priority review voucher to Pfizer after determining that its Paxlovid tablets meet the criteria for a material t...

Human Drugs

Lawmakers Want FDA Jurisdiction on Execution Drugs

Senators Cory Booker (D-NJ) and Elizabeth Warren (D-MA) urge the Department of Justice to rescind its Office of Legal Counsels 2019 opinion blocking F...

Federal Register

Palacio Debarred Over FDA False Statements

Federal Register notice: FDA permanently debars Jessica Palacio from providing services to any person that has approved or pending drug product applic...

Medical Devices

Respironics Recalls OmniLab Ventilator

Philips Respironics recalls (Class 1) its OmniLab Advanced + Ventilator because the device may experience an interruption or loss of therapy.

Medical Devices

Panel Backs Shield Colon Cancer Test

An FDA advisory committee recommends the approval of a Guardant Health PMA for the Shield blood test for colorectal cancer screening in adults age 45 ...

Human Drugs

Hospira Recalls Buprenorphine and Laberalol Lots

Pfizers Hospira drug unit recalls (Class 1) several lots of buprenorphine HCl injection Carpuject units and labetalol HCl injection Carpuject units du...

Human Drugs

Laurus Labs Cited on GMPs in India

FDA cites Laurus Labs (Hyderabad, India) over GMP deficiencies following a 12/2023 inspection at the firms active pharmaceutical ingredient manufactur...

Human Drugs

FDA Denies Ipsen Somatuline Depot Petition

FDA denies all five Ipsen Pharmaceuticals requests for agency actions on ANDAs for a generic form of Ipsens Somatuline Depot.

Human Drugs

8 New GDUFA Research Grants in FY 2023: Report

The FY 2023 GDUFA Science and Research Report examines GDUFA-funded research in eight priority areas affecting generic drug development and oversight.

FDA Seeks Mandatory Drug Recall, Other Powers

CDER, CBER, and CDRH directors tell Congress they need additional legal authorities to be able to continue to provide the services patients and provid...