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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...

FDA Clears CapsoVision Capsule Endoscope

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FDA clears a CapsoVision 510(k) for the CapsoCam Plus small bowel capsule endoscope system.

Debarment Order Against Edward Manookian

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Federal Register Notice: FDA issues a debarment order against Edward Manookian (also known as Ed Manning) based on a finding that ...

Novartis Gains Priority Review for Midostaurin in Leukemia

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FDA grants Novartis a priority review for an NDA for midostaurin, indicated for treating acute myeloid leukemia in newly-diagnosed...

Celebrex Passes FDA-ordered Safety Study: Pfizer

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Pfizer says that an FDA-ordered safety study of Pfizers arthritis drug Celebrex (celecoxib) demonstrated similar rates of cardiova...

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...