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Abbott/AbbVie Pay $25 Million in Off-Label Case

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Abbott Laboratories and its spin-off AbbVie agree to pay $25 million to resolve allegations that they used kickbacks and off-label...

Dangerous, Unethical Tests at Minn. Medical Center: Public Citizen

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FDA inspects a Minnesota medical center and finds violations that subjected unwitting patients to dangerous and unethical human te...

FDA Approves Jazz Pharmas Xyrem for Pediatric Cataplexy

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FDA approves a Jazz Pharmaceuticals supplemental NDA to revise labeling for Xyrem (sodium oxybate) oral solution to include an ind...

Latest Federal Register Notices

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FDA Review posts the Federal Register notices for the week ending 10/26/2018.

Comment Period Reopened on Sucralfate Guide

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Federal Register notice: FDA reopens the comment period for a revised draft product-specific guidance on sucralfate that appeared ...

Draft Guide on Biopharmaceutics Classification System Biowaivers

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Federal Register notice: FDA makes available a draft guidance entitled Biopharmaceutics Classification System-Based Biowaivers tha...

Shire Seeks Approval for Flexbumin Manufacturing Facility

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Shire files a submission seeking FDA approval for a new plasma manufacturing operation near Covington, GA to manufacture Flexbumin...

Regulatory Review Period Determined for Taltz

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Federal Register notice: FDA determines for patent extension-related purposes the regulatory review period for Eli Lillys Taltz (i...

Taiho Oncology sNDA for Lonsurf in Gastric Tumors

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FDA accepts for priority review a Taiho Oncology supplemental NDA for Lonsurf (trifluridine/tipiracil, TAS-102) as a treatment for...

Mixed Vote on Cardio Risk Trials for Diabetes Drugs

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An FDA Advisory Committee delivers a mixed vote (10 to 9) in favor of continuing required cardiovascular outcomes trials for all n...