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Human Drugs

Postmarketing Safety Electronic Submission Guidance

FDA publishes a guidance with general information on the electronic submission of specified postmarketing safety reports to CBER and CDER.

Medical Devices

Medtronic EMG Tube Airway Risk Evaluated

FDA says it is evaluating reports of an increased risk of airway obstruction associated with two Medtronic silicone-based EMG endotracheal tubes.

Federal Register

FDA Seeks Industry Rep for Pediatric Panel

Federal Register notice: FDA seeks industry organizations interested in participating in selecting a nonvoting industry representative to serve on the...

Medical Devices

Patels Goal as Chief Digital Health Officer

CDRH chief digital health officer of global strategy and innovation Bakul Patel explains the work he will be addressing in his new position.

Human Drugs

Multiple Clinical Resolution Laboratory Violations

FDA warns Brea, CA-based Clinical Resources Laboratory about CGMP violations in its production of misbranded unapproved new drugs.

No Major Changes in Intended Use Reg: Attorney

Attorney Bryan Feldhaus says the revised FDA intended use regulation clarifies but does not change the definition of intended use and should not adver...

Human Drugs

Repeat CGMP Violations at Vitae Enim Vitae

FDA warns San Diego, CA-based Vitae Enim Vitae Scientific about repeat CGMP violations in its work producing finished drugs as a contract manufacturer...

Biologics

House Committee Wants Kid Covid Vaccine Briefing

The House Select Subcommittee on the Coronavirus Crisis is asking for an FDA briefing on the status of vaccination for children under age 5 and whethe...

FDA Featured in DoJ Consumer Highlights Report

Wilson and Sontini attorneys say the Department of Justice Consumer Protection Bureau featured FDA in its recent highlights report.

Federal Register

FDA Withdraws 14 No-Longer-Marketed ANDAs

Federal Register notice: FDA withdraws the approval of 14 no-longer-marketed ANDAs from multiple applicants.