FDA Related News

Human Drugs

Former FDAer John Jenkins Joins Corbus Board

Former Office of New Drugs director John Jenkins joins the Corbus Pharmaceuticals board.

Federal Register

Sun Pharma Not Withdrawing Benazepril HCl/Hydrochlorothiazide

Federal Register notice: FDA corrects a 2/23 notice announcing that Sun Pharmaceutical Industries asked to withdraw its generic benazepril hydrochlori...

Human Drugs

FDA Nixes Mylan/Biocon Lantus Biosimilar

FDA rejects Mylan/Biocons biosimilar application for a Lantus follow-on due to manufacturing site questions.

Human Drugs

Injunction Sought Against Innovative BioDefense

FDA files a complaint seeking a permanent injunction against Innovative BioDefense (Lake Forest, CA) and president/CEO Colette Cozean to prohibit them...

Medical Devices

EOS Imaging Hip Surgical Planning Software Cleared

FDA clears an EOS Imaging 510(k) for its hipEOS 3.0 surgical planning software.

Medical Devices

FDA Clears Phillips New MR System

FDA clears a Royal Philips 510(k) for the Ingenia Elition 3.0T magnetic resonance (MR) device and two clinical applications, Philips Compressed SENSE ...

Human Drugs

FDA Wants More Efficient Drug Development Continuum

FDA commissioner Scott Gottlieb says the agency is taking steps to make the drug development continuum more efficient and cost-effective.

Creative Science Marketing Unapproved New Animal Drug: FDA

FDA warns Creative Science it is marketing an unapproved new animal drug.

Human Drugs

Generic Drug Savings $8.8 Billion in 2017: FDA

FDA estimates 2017 generic drug approval cost-savings at $8.8 billion.

Human Drugs

CGMP Violations in Kolmar Korea Co. Inspection

FDA warns South Koreas Kolmar Korea Co. about CGMP violations in its production of finished pharmaceuticals.