FDA Related News

Human Drugs

Cape Drugs FDA-483

FDA releases the FDA-483 with four observations issued following an inspection at Annapolis, MD-based Cape Drugs.

Human Drugs

AbbVie to Submit Qulipta sNDA to Expand Indication

AbbVie says it will submit an sNDA to FDA to expand the indication for its Qulipta to include preventive treatment of chronic migraine.

Human Drugs

ODAC Meeting Signals Need for FDA Contact: Attorneys

Two Morrison Foerster attorneys describe lessons learned from an Oncologic Drugs Advisory Committee meeting that voted to recommend additional clinica...

Health Subcommittee to Review 20 FDA/Health Bills

The House Energy and Commerce Committee Health Subcommittee announces a 3/17 hearing entitled The Future of Medicine: Legislation to Encourage Innovat...

Medical Devices

FDA Clears Photon Counting Detector in CT Scanning

FDA clears a NeuroLogica 510(k) for the addition of Photon Counting Detector technology to its OmniTom Elite 16-slice computed tomography scanner.

Human Drugs

Supply Chain Act Drug Verification System Guidance

FDA publishes a draft guidance with its interpretation of requirements for verification systems for certain prescription drugs under the Drug Supply C...

Human Drugs

12 Observations in SterRx FDA-483

FDA releases a 26-page FDA-483 with 12 observations from an inspection at Plattsburgh, NY-based StarRx outsourcing facility.

Human Drugs

Some IVIG and IGSC Lots Withdrawn

FDA lists lots of immune globulin intravenous and subcutaneous that have been withdrawn due to reports of allergic/hypersensitivity reactions.

Human Drugs

Steps FDA Could Take to Increase Trial Diversity

A Trinity Life Sciences white paper on clinical trial diversity says FDA should change its policy and install minimum representation requirements.

Medical Devices

Medtronic Recalls TurboHawk Atherectomy System

Medtronic recalls its TurboHawk Plus Directional Atherectomy System because it is similarly designed as another recently recalled device.