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Steiner Biotechnology Objectionable Conditions Cited

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FDA warns Steiner Biotechnology about violations in its conduct of nonclinical laboratory studies.

FDA Wants to Reclassify 2 Hep C Tests

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FDA proposes to reclassify two types of hepatitis C diagnostic tests from Class 3 to Class 2 with special controls.

Regs Amended on 510(k)-Exempt Devices

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Federal Register notice: FDA amends certain medical device regulations to accurately reflect the devices exempted from premarket n...

Pull Zantac and Generics from Market: FDA

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FDA asks manufacturers of all Rx and OTC ranitidine products to remove them from the market due to NDMA contamination.

CDRH Organization Structures Amended in Regs

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Federal Register notice: FDA amends its medical device regulations to reflect changes to CDRHs organizational structure, including...

FDA Posts Animal Drug Approval Docs

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Federal Register notice: FDA amends the animal drug regulations to reflect application-related actions made during the first quart...

Rescind Voltaren OTC Approval: Petition

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The Wiley Rein law firm asks FDA to rescind its approval of OTC status for diclofenac gel 1% unless revisions are made to the labe...

Comments on OPDP Endorser Status Research

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Two stakeholders raise concerns with proposed direct-to-consumer advertising research into celebrity endorsements.

Minor Revisions Suggested for FDA Bridging Guidance

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AdvaMed proposes minor revisions to an FDA draft guidance on combination product bridging.

White House Continues Effort to Speed Virus Therapies

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The Trump administration continues to put political pressure on FDA to speed access to potential coronavirus treatments.