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DePuy Synthes Recalls Exploding Surgical Tool Batteries

[ Price : $8.95]

DePuy Synthes recalls its Small Battery Drive and Small Battery Drive II Adaptor and Light Adaptor, which are used in the companys...

Infuse Cases Dismissed

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An Ohio federal court dismisses all elements in a consolidated claim by five plaintiffs against Medtronic alleging various forms o...

FDA Clears Medtronic StealthStation Cranial Software

[ Price : $8.95]

FDA clears a Medtronic 510(k) for the StealthStation cranial software as an aid for deep brain stimulation lead placement.

FDA Clears Quidel Influenza Assay

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FDA clears a Quidel 510(k) to market its Solana Influenza A+B assay for detecting nucleic acids isolated from nasal and nasopharyn...

FDA Clinical Hold on CEl-SCI Multikine Phase 3 Study

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FDA places a clinical hold on a CEL-SCI Corp. Multikine (leukocyte interleukin injection) Phase 3 clinical trial in advanced prima...

FDA Again Rejects Pain Therapeutics Remoxy NDA

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FDA sends Pain Therapeutics a third complete response letter on its NDA resubmission for Remoxy ER (oxycodone capsules), asking fo...

PhRMA Wants Kickback Decision Reconsidered

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PhRMA says a Massachusetts federal court should certify for appeal its flip-flop decision that ultimately ruled that CCS Medical S...

Latest FDA Warning Letters

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In its latest batch of Warning Letters, FDA cites Ajes Pharmaceuticals, Cheng Fong Chemical Co., and Elite Laboratories.

Differentiating Literally False and Impliedly False Ads

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Attorney Sandra Edelman describes the legal distinction applied by the 2nd Circuit Appeals Court in determining whether an adverti...

CGMP Violations at Cheng Fong Chemical

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FDA warns Chinas Cheng Fong Chemical CGMP violations in its production of active pharmaceutical ingredients.