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Human Drugs

CNS Drugs Longer to Develop, Approve: Tufts Center

A Tufts Center for the Study of Drug Development analysis shows that central nervous system drugs take longer to develop and approve than drugs in oth...

Medical Devices

FDA Finds Violations in 2 Medtronic Inspections

FDA warns two Medtronic manufacturing facilities about Quality System violations in their production of cardiac medical devices.

Medical Devices

Integrate Cybersecurity in Medical Device Reviews: OIG

The HHS Inspector General outlines steps FDA could take to better integrate cybersecurity concerns into its medical device reviews before granting mar...

Federal Register

Panel to Review Pain Drug

Federal Register notice: FDA announces a 10/11 Anesthetic and Analgesic Drug Products Advisory Committee meeting.

Federal Register

Joint Advisory Panel to Review Irritable Bowel Drug

Federal Register notice: FDA announces a 10/17 joint advisory committee meeting to review an irritable bowel syndrome drug.

Human Drugs

CGMP Violations Found in Lernapharm Inspection

FDA warns Canadas Lernapharm about CGMP violations in its production of finished drugs.

Human Drugs

Comments on Draft Indications and Usage Labeling Guidance

Four pharmaceutical stakeholders submit comments on an FDA draft guidance on writing the Indications and Usage section in product labeling.

Human Drugs

Procedural Deficiency in Lupin Tarapur Inspection

Indias Lupin says an FDA inspection at its Tarapur drug manufacturing facility closed with one observation the company considers to be a procedural de...

Human Drugs

CGMP Violations at Chinas Longwood Medicine (Beijing)

FDA warns Chinas Longwood Medicine (Beijing) about CGMP violations in its production of an unapproved new drug.

Federal Register

Guide on Drug Substance Postapproval Changes

Federal Register notice: FDA makes available a draft guidance entitled Postapproval Changes to Drug Substances.