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FDA General

FDA Plans Rule to Require Full Risk Info in Drug Ads

FDA plans to publish a proposed rule by the end of the year that would require prescription drug advertisements on television, radio and similar broad...

Human Drugs

OIG Backs Manufacturer-Sponsored Patient Tests

Two Sheppard attorneys discuss an HHS Inspector General advisory opinion backing a drug companys arrangement with a third-party laboratory for free an...

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Biologics

Former CDC Official Alleges Political Interference In Vaccine Policy

During a CBS News interview, former CDC chief medical officer Debra Houry says she left the agency after concluding she could no longer defend its sci...

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FDA General

Insufficient Data on 7 Peptides for Potential Compounding Use: FDA

FDA briefing materials show that agency reviewers have found limited evidence supporting the safety and effectiveness of seven peptide substances that...

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Marketing

FDA Sued Over Rejection of Supplement Ad Claims

Three Benesh Friedlander Coplan & Aronoff attorneys say a suit against FDA filed by the Alliance for Natural Health USA could change the way that supp...

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Biologics

Blood Donor Screening in an Ebola Outbreak

FDA publishes a guidance notifying blood establishments about agency recommendations for screening and deferring blood donors in response to an Ebola ...

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Human Drugs

Repeat CGMP Violations Seen in Excelvision Inspection

FDA warns Excelvision about CGMP violations in the production of drugs at its facility in Annonay, France.

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Human Drugs

Genzyme Ireland Inspection Documents CGMP Issue

FDA warns Genzyme Ireland about the failure of the firms quality control unit to ensure that drugs comply with CGMP requirements.

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Medical Devices

Abiomed Impella Heart Pump Recall is Class 1

FDA says the Abiomed recall of certain Impella CP Sets with SmartAssist is Class 1.

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Medical Devices

Insulet Omnipod Pod Recall is Class 1: FDA

FDA says an Insulet recall of specific lots of its Omnipod Pods is Class 1.