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Drug Warning Letters More than Doubled in 2016: Analysis

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An Unger Consulting analysis finds that the number of FDA GMP Warning Letters more than doubled from FY 2015 to FY 2016.

Doctors Favor Biologic Name Suffixes: Poll

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Doctors surveyed by the Biologics Prescribers Collaborative say they favor a meaningful four-letter suffix denoting the manufactur...

Bayers Essure Gets Boxed Warning, Patient Checklist

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FDA says that Bayers controversial Essure permanent birth control system has new labeling that includes a Boxed Warning and a Pati...

Five Possible Trump Administration Impacts

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Attorney James Beck looks at five ways that a Trump administration could affect FDA and its regulated industries.

OPQ Site Visit Locations Sought

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The CDER Office of Pharmaceutical Quality solicits proposals from drug companies wanting to participate in an agency site visit pr...

Latest FDA Warning Letters

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In its latest batch of Warning Letters, FDA cites Morton Drug Co. and Sekisui Medical Co.

Medtronic Claria MRI Quad Defibrillator Approved

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FDA approves Medtronics Claria MRI Quad Cardiac Resynchronization Therapy Defibrillator (CRT-D) SureScan device for patients with ...

Comments Sought on Anti-tobacco Campaign

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Federal Register Notice: FDA asks for comments on a new information collection related to an anti-tobacco campaign.

Debarment Order Against Paul Singh

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Federal Register Notice: FDA issues a debarment order against Paul S. Singh for providing services in any capacity to a person tha...

Debarment Order Against Louis Daniel Smith

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Federal Register Notice: FDA issues a debarment order against Louis Daniel Smith from providing services in any capacity to a pers...