FDA Related News

Medical Devices

Medical Device Feedback/Meeting Guidance

FDA issues a draft guidance updating mechanisms available to submitters to request agency feedback or a meeting on a variety of medical device applica...

Federal Register

Panel to Review GSK COPD Add-on Therapy

Federal Register notice: FDA announces a 7/25 Pulmonary-Allergy Drugs Advisory Committee meeting.

Medical Devices

Tiger Selling Restricted Alere Test Kit: FDA

CBER says Tiger Medical is selling the Alere HIV combo test kit without ensuring that restrictions that are part of the kits approval are applied.

Human Drugs

5 Observations in Glenmark Inspection

FDA releases the FDA-483 issued following an inspection at Indias Glenmark Pharmaceuticals.

Human Drugs

Partner Therapeutics Drug Approved for Radiation Sickness

FDA approves a Partner Therapeutics NDA for leukine for treating adult and pediatric patients acutely exposed to myelosuppressive doses of radiation.

Human Drugs

Amag NDA for Hypoactive Sexual Desire Disorder Drug

FDA accepts an Amag Pharmaceuticals NDA for bremelanotide, a first-in-class melanocortin 4 receptor agonist for treating hypoactive sexual desire diso...

Medical Devices

FDA Clears Rodo Medical Smilekey Induction Remover

FDA clears a Rodo Medical 510(k) for the Rodo Smilekey, an induction remover device for use with the Rodo Abutment System.

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.

Stop Selling Illegal Opioids, FDA Warns Online Nets

FDA warns operators of 53 Web sites to stop illegally selling opioids.