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Panel to Discuss 2 NDAs

[ Price : $8.95]

Federal Register Notice: FDAs Endocrinoloigc and Metabolic Drugs Advisory Committee will meet 1/12-13/10 to discuss an Acetelion P...

Vaccines and Related Bio Products Panel to Meet

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Federal Register Notice: FDAs Vaccines and Related Biological Products Advisory Committee will meet 12/15 to hear updates on vario...

Advisors Back Prevnar 13 Safety, Efficacy

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FDAs Vaccines and Related Biological Products Advisory Committee votes 10-1 to recommend that clinical trial data support safety a...

FDA Approves Revatio IV, Denies Citizen Petition

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FDA approves Pfizers NDA for Revatio solution for injection and denies most of a citizen petition seeking to put requirements on s...

P&G Recalls 3 Lots of Vicks Sinex

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Procter & Gamble recalls three lots of its Vicks Sinex nasal spray after quality control testing found the bacteria B. cepacia in ...

Advisors Recommend Against Xolair

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FDAs Pulmonary-Allergy Drugs Advisory Committee recommends the agency not approve an expanded indication for Noavartis/Genentechs ...

Genzyme Dropping Advanced Phosphate Binder Development

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Genzyme says it is stopping development of an advanced phosphate binder that didnt show significantly better lowering of phosphate...

Info on Xenotransplantation Sent to OMB

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Federal Register Notice: FDA sends a proposed collection of information on infectious disease issues in xenotransplantation to the...

Public Meeting on REMS for Opioid Drug Products

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Federal Register Notice: FDA plans a public meeting 12/4 to discuss Risk Evaluation and Mitigation Strategies for certain opioid d...

Info on User Fee Cover Sheet Sent to OMB

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Federal Register Notice: FDA sends a proposed collection of information on the user fee cover sheet to the Office of Management an...