FDA Related News

Human Drugs

GMP Violations in YangZhou Records Review

FDA warns Chinas YangZhou SuXiang Medical Instrument Co. about CGMP violations in its manufacturing of finished drugs.

Human Drugs

CGMP Violations at Jiangsu Hengrui

FDA warns Chinas Jiangsu Hengrui Pharmaceuticals about CGMP violations in its manufacturing of finished drugs

Combination Product Application User Fees

FDA publishes a guidance on how it calculates combination product application user fees.

Human Drugs

FDA Accepts Lexicon NDA for Resubmitted Diabetes Drug

FDA accepts for review a resubmitted Lexicon Pharmaceuticals NDA for Zynquista (sotagliflozin) as an adjunct to insulin therapy for glycemic control i...

Human Drugs

Guidance on Pediatric IBD Drug Development

FDA publishes a draft guidance for sponsors working to develop drugs to treat pediatric inflammatory bowel disease.

Human Drugs

FDA Wants to Stem Common Chronic Diseases: Califf

FDA commissioner Robert Califf says many stakeholders need to work together to improve interventions for common chronic diseases.

Medical Devices

Smith+Nephew New Hip System Cleared

FDA clears a Smith+Nephew 510(k) for its new Catalystem Primary Hip System.

Biologics

Issues in MIT Institutional Review Board

FDA warns the MIT IRB on using humans as experimental subjects about repeat violations of regulations.

Human Drugs

FDA OKs Phase 3 Trial of Lumbar Cell Therapy

FDA gives DiscGenics the go ahead for a Phase 3 clinical trial after agreeing to the clinical protocols and chemistry, manufacturing, and controls cli...

Human Drugs

Orexo Complete Response on Naloxone NDA

FDA gives Orexo AB a complete response letter on its NDA for OX124, a high-dose naloxone rescue medication for opioid overdose.