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Advisors Considering CoAxia Catheter

[ Price : $8.95]

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

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

[ Price : $8.95]

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

CDRH Officials Address Diabetes Patients on Agency Slowness

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In an unprecedented move, three CDRH officials address review/approval slowness on a diabetes patient blog.

FDA Says Heparin Product Labeling Changing

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FDA says labels for two heparin products will change to list the strength of the entire container of the medication and how much o...

Trimel Plan NDA for Testosterone Replacement Therapy

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Trimel Pharmaceuticals says it is preparing an NDA for CompleoTRT (testosterone) for use as a replacement therapy.

FDA OKs Lipocine Phase 3 Trial for Testosterone Replacement

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FDA clears a Lipocine Phase 3 study of its oral testosterone replacement therapy.

Guidance on Limiting Phthalates as Excipients in Drugs/Biologics

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Federal Register Notice: FDA releases a guidance, Limiting the Use of Certain Phthalates as Excipients in CDER-Regulated Products.

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...