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B&L Whistleblower Gets 2nd Chance to Make Case

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The 11th Circuit appeals court returns to a lower court a Bausch & Lomb whistleblower case to determine if a causal connection exi...

Advisors Unanimously Recommend Simeprevir Approval

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Members of FDAs Antiviral Drugs Advisory Committee unanimously recommend approval of Janssens simeprevir in treating some cases of...

NPS Pharma Files BLA for Natpara

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NPS Pharmaceuticals submits a BLA for Natpara (recombinant human parathyroid hormone 1-84, rhPTH).

GPhA Asks Many Questions About Stability Guidance

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The Generic Pharmaceutical Association asks FDA many questions about its draft guidance on stability testing for ANDAs.

CDER Opens Web Page for IND Investigators

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CDER launches a Web navigational tool for academic investigators working on IND applications.

Comments Sought on Therapeutic Area Standards Plan

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FDA releases for comment the Therapeutic Area Standards project plan for PDUFA 5 drug and biologic clinical terminology standards....

Public Citizen Wants to Silence Advisory Committee Chair

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Public Citizen wants a ban on FDA advisory committee members making presentations to industry on how best to get a favorable decis...

U.S. Oncology, BioMarin Begin Phase 3 Study in BRCA Breast Cancer

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U.S. Oncology Research and BioMarin Pharmaceutical collaborate to launch a Phase 3 study of BMN 673, a poly ADP-ribose polymerases...

FDA Releases Therapeutic Area Standards Plan

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Federal Register Notice: FDA makes available the Therapeutic Area Standards Initiative Project Plan.

Guidance on Nucleic Acid Tests to Reduce West Nile Virus

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Federal Register Notice; FDA releases a draft guidance on the use of nucleic acid tests to reduce the transmission of West Nile Vi...