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Human Drugs

FDA Targets 17 Online Unapproved Product Marketers

FDA issues 12 Warning Letters and 5 online advisory letters to companies that are illegally selling more than 58 products that are unapproved or misbr...

FDA General

Latest Federal Register Notices

FDA Review posts the Federal Register notice for the week ending 2/8/2019.

FDA General

Product Approval Summaries

FDA Review posts product approval summaries for the week ending 2/8/2019.

Federal Register

FDA Seeks Industry Reps to Serve on Advisory Committees

Federal Register notice: FDA requests nominations for nonvoting industry representatives to serve on its public advisory committees for CDER.

Federal Register

Info Collection Extension for Generic Drug Fee Coversheet

Federal Register notice: FDA submits to OMB an information collection extension for its Generic Drug User Fee Coversheet.

Federal Register

Pilot Program on Drug Supply Chain

Federal Register notice: FDA announces the start of a pilot program under the Drug Supply Chain Security Act.

Federal Register

Public Warnings on Recalls Guidance

Federal Register notice: FDA makes available a final guidance entitled Public Warning and Notification of Recalls.

Medical Devices

Orthofix Artificial Cervical Disc Approved

FDA approves an Orthofix Medical PMA for the M6-C artificial cervical disc for patients suffering from cervical disc degeneration.

Human Drugs

Perrigo Gains ANDA Approval for Generic Zovirax

FDA approves a Perrigo ANDA for a generic copy of GlaxoSmithKlines Zovirax Cream, 5% (acyclovir cream).

Medical Devices

Guide to Exempt Well Understood Devices from 510(k)

FDA releases a guidance entitled Intent to Exempt Certain Unclassified Medical Devices from Premarket Notification Requirements.