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Research Mulls Approach to Qualify Patient-reported Measures

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New research supported by CDRHs Division of Biostatistics outlines an approach that could lead to more patient-reported outcome me...

Circulatory System Device Panel to Meet 12/4-5

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Federal Register notice: FDA announces a12/4-5 Circulatory System Devices Panel of the Medical Devices Advisory Committee.

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Federal Register notice: FDA makes available a draft guidance entitled Biopharmaceutics Classification System-Based Biowaivers tha...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