FDA Webview
X
about-us-banner

FDA Related News

Home / Articles / FDA Related News
Human Drugs

FDA Names Companies Potentially Blocking Generic Samples

FDA publishes the names of drug companies it says may be blocking generic drug developers from obtaining needed samples.

Human Drugs

Vermont Allows Canadian Drug Imports

Vermont becomes the first state to approve a law allowing U.S. drug wholesalers to import prescription drugs from Canadian drug wholesalers.

Human Drugs

FDA Backs Away From McClellan Contract: Report

FDA backs away from awarding a sole source contract to a center run by former commissioner Mark McClellan,

Human Drugs

Amneal Pharma Gains Approval for Generic Welchol

FDA approves an Amneal Pharmaceuticals ANDA for a generic version of Daiichi Sankyos Welchol (colesevelam HCI) tablets, 625 mg.

Medical Devices

Certain Surgical Apparel 510(k) Exempt

Federal Register notice: FDA posts a final order to exempt certain surgical apparel from premarket notification requirements, subject to conditions an...

Human Drugs

Experts Offer Pharmaceutical Reform Plan

Healthcare experts offer a plan for comprehensive reform of the U.S. pharmaceutical system.

Medical Devices

Additive Orthopedics 3D-printed Bone Segments Cleared

FDA clears an Additive Orthopedics 510(k) for its Patient Specific 3D Printed Bone Segments for internal bone fixation in the ankle and foot.

Human Drugs

PA Court Upholds Actiq Suit Preemption

The Pennsylvania Superior Court upholds dismissal of a suit alleging a patient died as a result of off-label promotion of Teva/Cephalons Actiq for tre...

Federal Register

OMB Approves 6 Info Collection Requests

Federal Register notice: FDA posts a list of recent information collections that have been approved by OMB.

Human Drugs

Info Collection Extension for User Fee Refund Requests

Federal Register notice: FDA seeks public comments on an information collection extension entitled Electronic User Fee Payment Request Forms Form FDA...