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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...

Trump to Lower FDA Approval Standards: ex-Pfizer Exec LaMattina

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Former Pfizer Global Research and Development president and Forbes contributor John LaMattina believes FDA will lower its approval...

2 Outdated Proposed Rules on Gene Therapies and Crabmeat Withdrawn

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Federal Register Notice: FDA withdraws two proposed rules published over five years ago because they are outdated.

Thermo Fisher PMA for Lung Cancer Assay

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Thermo Fisher Scientific files the final module of a PMA for its Oncomine Universal Dx Test, a multi-gene, next-generation sequenc...