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Circuits Split on Medical Device Suit Preemption

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Attorney Matthew Reed reviews divided appeals court cases on preemption of medical device lawsuits and says the Supreme Court need...

Biodel Gains Orphan Drug Status for Glucagon

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FDA grants Biodel Inc. an orphan drug designation for glucagon and its use in preventing hypoglycemia in the congenital hyperinsul...

FDA Approves Devicor Biopsy System

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FDA approves Devicor Medical Products Mammotome Revolve, a dual vacuum-assisted biopsy system used to provide tissue specimens.

Advisors Considering CoAxia Catheter

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FDA asks the Neurologic Devices Panel to comment on the safety and effectiveness of the CoAxia NeuroFlo catheter based on premarke...

FDA Proposes to Revise Animal Drug Regs for Tolerances/Residues

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Federal Register Proposed rule: FDA proposes to revise the animal drug regulations to standardize, simplify, and clarify the deter...

Guidance on Limiting Phthalates as Excipients

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A CDER guidance recommends against using DBP and DEHP as excipients in drug and biologic products.

CDER Denies Generic Copaxone Restriction Request

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FDA denies a Teva petition seeking limitations on approving generic forms of Copaxone without comment on specific requirements it ...

Reviewers Question Zohydro ER Abuse Potential

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CDER medical reviewers say they believe that Zogenix Zohydro ER may be more subject to abuse than combination hydrocodone products...

Chelsea Therapeutics: Positive Results in Parkinsons Trial

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Chelsea Therapeutics International reports positive preliminary results for Study 306B, a Phase 3 trial evaluating Northera for tr...

CDRH Lists 6 Strategic Priorities

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CDRH releases its six strategic priorities for 2013.