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FDA Orphan Status for Atox Bio Therapy

[ Price : $8.95]

FDA grants an orphan drug designation to Atox Bio for AB103 and its use for treating necrotizing soft tissue infections.

FDA Panel To Address AtriCure PMA Questions

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CDRH reviewers say it appears that a clinical trial intended to support approval of an AtriCure PMA for its Synergy Ablation devic...

Science Gains Could Cut Politicization, Scrutiny: Woodcock

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CDER director Janet Woodcock predicts that scientific and technological advances could alleviate drug develop turmoil and thus dec...

OMB OKs Info on Temporary Marketing Permits

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Federal Register Notice: The Office of Management and Budget approves a collection of information on temporary marketing permit ap...

Comments Sought on Animal Drug Bioequivalence

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Federal Register Notice; FDA seeks comments on the burden hours required for reviewing requests for waiver of in vivo demonstratio...

Panel to Discuss NDA for Adults with Schizophrenia or Bipolar I

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Federal Register Notice: FDAs Psychopharmacologic Drugs Advisory Committee will meet 12/12 to discuss Alexza Pharmaceuticals NDA f...

FDA Clears Abbott Diagnostic for Leukemia Patients

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FDA grants 510(k) clearance to Abbott for its Vysis EGR1 FISH Probe Kit to aid in assessing an overall prognosis for acute myeloid...

Transparency Blocked on Transparency Workshop

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Public interest group Judicial Watch releases emails from the White House showing how it orchestrated a block on reporters seeking...

FDA OKs Onfi for Certain Seizures

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FDA approves a Lundbeck NDA for Onfi tablets (clobazam) for use as an adjunctive treatment for seizures associated with Lennox-Gas...

FDA Studies Support Current Chantix Warnings

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FDA says that recent data from two studies show that Pfizer's smoking cessation drug Chantix (varenicline) is appropriately labele...