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AnazaoHealth FDA-483

[ Price : $8.95]

FDA releases an FDA-483 with three observations issued following an inspection at AnazaoHealth.

Mullin Reelected ICH Management Committee Chair

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The International Council on Harmonization reelects FDAer Theresa Mullin to a one-year term as chair of its management committee.

QS Violations Found at American Contract Systems

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FDA warns American Contract Systems about Quality System violations in its work manufacturing medical devices and acting as a cont...

Review Period for Amgens Aimovig

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Federal Register notice: FDA determines for patent extension purposes the regulatory review period for Amgens Aimovig (erenumab-ao...

Hahns FDA Nomination Heads to Full Senate

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Senate Health, Education, Labor & Pensions Committee votes 18 to 5 to advance Stephen Hahns nomination to serve as FDA commissione...

Guide on Drug Trial Adaptive Designs

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Federal Register notice: FDA makes available a final guidance entitled Adaptive Designs for Clinical Trials of Drugs and Biologics...

Lawmakers Push for UDIs on Insurance Forms

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Five bipartisan members of Congress ask HHS and CMS to include unique device identifiers on health insurance claims forms to enhan...

Nubratori Rx FDA-483

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FDA releases the FDA-483 with three observations from an inspection at Nubratori, Inc.

Immunomedics Re-files for Breast Cancer Therapy

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Immunomedics resubmits its BLA seeking accelerated approval for sacituzumab govitecan, indicated for treating certain patients wit...

Judicial Deference to FDA More Uncertain: Analysis

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A Ropes&Gray legal analysis says a recent Supreme Court decision could make it easier for regulated companies to argue against cou...