FDA Related News

Federal Register

Annual Postmarketing Requirements Report Posted

Federal Register notice: FDA makes available an annual report entitled Report on the Performance of Drug and Biologics Firms in Conducting Postmarketi...

Medical Devices

Device Conformity Assessment Pilot Becoming Permanent

CDRHs Accreditation Scheme For Conformity Assessment pilot program transitions to a permanent program based on review efficiencies it has demonstrate...

Human Drugs

Man Fakes Cancer to Skip FDA Misbranding Trial

An FDA criminal case involving a Mays Landing, NJ, man who marketed a toxic chemical as a weight-loss drug online has led to a guilty plea on an obstr...

Human Drugs

GSKs Oral Anemia Drug Approved for Dialysis

FDA approves a GlaxoSmithKline NDA for Jesduvroq (daprodustat) tablet that it describes as the first oral treatment for anemia caused by chronic kidne...

Human Drugs

Greenleaf Health Hires 2 Former FDA Officials

Regulatory consulting firm Greenleaf Health brings onboard two former FDA officials former Office of Compliance Don Ashley and former FDA Europe Offi...

Human Drugs

FDA Warning, Import Alert on Contaminated Eyedrops

FDA issues an import alert and a safety alert on EzriCare Artificial Tears or Delsam Pharmas Artificial Tears due to potential bacterial contamination...

Medical Devices

Philips BiPAP, CPAP Mask Recall is Class 1: FDA

FDA says the Philips Respironics recall of specified BiPAP and CPAP masks for a safety concern was Class 1

Human Drugs

FDA Strategy on Opioid Reversal Products Nears Fruition

FDA outlines its ongoing strategy to expand access to overdose reversal products that has reached a milestone by having upcoming advisory committee me...

Human Drugs

PMR/PMC Annual Statistical Report

FDA says most postmarketing reports and commitments are generally progessing on schedule, according to the FY 2021 annual report.

Consider Mfg. Issues in Preparedness Planning: GAO

The Government Accountability Office says a new HHS program to produce medical countermeasures such as drugs and vaccines should assess challenges and...