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FDA Cites Lundbeck Over Vyepti Promotional Claims

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FDA sends Lundbeck Seattle Biopharmaceuticals an untitled letter alleging that promotional materials for its migraine therapy Vyep...

Saol Therapeutics Resubmits Rare Disease Therapy SL1009

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Saol Therapeutics refiles its NDA for SL1009 (sodium dichloroacetate), an investigational treatment for pyruvate dehydrogenase com...

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...

FDA Plans Rule to Require Full Risk Info in Drug Ads

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

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.