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MDUFA Performance Goals, Procedures for 2028-2032

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FDA releases the draft MDUFA performance goals and procedures approved by CDRH and CBER for the 2027 renewal of MDUFA that will co...

OIG Backs Manufacturer-Sponsored Patient Tests

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

Former CDC Official Alleges Political Interference In Vaccine Policy

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

Insufficient Data on 7 Peptides for Potential Compounding Use: FDA

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

FDA Sued Over Rejection of Supplement Ad Claims

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

Blood Donor Screening in an Ebola Outbreak

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FDA publishes a guidance notifying blood establishments about agency recommendations for screening and deferring blood donors in r...

Repeat CGMP Violations Seen in Excelvision Inspection

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

Genzyme Ireland Inspection Documents CGMP Issue

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

Abiomed Impella Heart Pump Recall is Class 1

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

Insulet Omnipod Pod Recall is Class 1: FDA

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