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FDA Orphan Status for Stem Cell Therapy

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FDA grants California Stem Cell, Inc. an orphan drug designation for Motorgraft, a stem cell-derived motor neuron product for trea...

Panel to Discuss Cymbalta For Chronic Pain

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Federal Register Notice: FDAs Anesthetic and Life Support Drugs Advisory Committee will meet 1/28/10 to discuss safety and efficac...

Oncologic Drugs Panel Notice Amended

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Federal Register Notice: FDA amends the notice of the 12/16 Oncologic Drugs Advisory Committee meeting to reflect the cancellation...

Latest FDA Warning Letters

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In its latest batch of Warning Letters, FDA cites Aluwe, Burzynski Research Institute IRB, Chi Machine, Icon Clinical Research, PM...

New Research Disputes FDA Warning on Antiepileptic Drugs

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New research calls into question a recent FDA-ordered warning about an increased risk of suicidal thoughts and actions associated ...

Are the FDA Regional Offices a Value-added Function?

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Consulting editor John Scharmann reviews the history of FDAs regional offices and asks whether they have a value-added function.

FDAs Internet Communications Challenge: Macro vs. Micro

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FDA affairs commentator Steven Gross says the agency is on the wrong course in its efforts to develop an all-encompassing single p...

FDA Urges Attention to CT Perfusion Rad Dosage

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FDA says that facilities and CT technologists should take steps to ensure that patients undergoing CT perfusion scans are not expo...

FDA OKs Octapharma Anti-bleeding Therapy

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FDA approves Octapharmas wilate for treating spontaneous and trauma-induced bleeding episodes in patients with all types of von Wi...

Nutra Pharma Ready to Launch Nyloxin

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Nutra Pharma says it will launch OTC and Rx versions of its pain reliever Nyloxin.