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Grassley Asks 31 Health Organizations for Industry Funding Info

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Sen. Charles Grassley asks 31 health and medical professional organizations for detailed information on their funding from drug an...

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...

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 ...

FDA Publishes Patient-report Outcomes Guidance

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FDA issues a guidance explaining how it reviews and evaluates patient-reported outcome instruments used to support medical product...

FDA Staff Concerned About Cayston Trials

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FDA tells the Anti-infective Drugs Advisory Committee that there are staff concerns about the clinical trials submitted to support...

Dey Wants FDA Restrictions on Generic EpiPens

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Dey Pharma petitions FDA not to approve generic EpiPen ANDAs unless they have exactly the same design, operation, and function, in...

Drug Ad Spend Down Slightly in 2009

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TNS Media Intelligence says that drug company ad spending has been essentially flat in the first nine months of this year compared...

Administration Increases Open Government Efforts

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The Obama Administration lays out deadlines for agencies to improve their open government activities.