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Cepheid Ab Inspection Finds QS Issues

[ Price : $8.95]

FDA warns Swedens Cepheid Ab about Quality System violations in its manufacturing of the Xpert Norovirus.

Abbotts Depakote Gets a Partial Win in Liability Case

[ Price : $8.95]

Attorney James Beck says an Ohio federal court dismissed several of the most serious claims against Abbott over the pregnancy risk...

Appeals Panel Thwarts Removal of Class, Mass Actions: WLF

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Washington Legal Foundation says that a 9th Circuit Court three-judge ruling in a case involving removal from state to federal cou...

FDA Accepts Boehringer NDA for Gilotrif

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FDA accepts for review a Boehringer Ingelheim NDA for Gilotrif (afatinib) for treating patients with advanced squamous cell carcin...

Report on National Device Evaluation System

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Federal Register Notice: FDA makes available a report and Web site location on recommendations for a national medical device evalu...

QS Issues Found at New May King Plastic

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FDA warns Chinas New May King Plastics about 12 Quality System violations in its manufacturing of Class 1 and 2 massagers.

Allergan Recalls Ophthalmic Products Due to Black Particles

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Allergan recalls several lots of its ophthalmic ointments due to reports about small black particles present in the products.

Latest FDA Warning Letters

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In its latest batch of Warning Letters, FDA cites Cane, Cepheid, Euromi, Dr. Bernard A. Michlin, and New King May King Plastic.

CDER Defends Review Division Inconsistency Criticism

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Responding to a recent study that criticized CDER inconsistent performance across its review divisions, CDER officials say that re...

Comments Sought on Dietary Supplement Labeling

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Federal Register Notice: FDA seeks comments on provisions in a guidance on the labeling of dietary supplements as required by the ...