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Former Restaurant Association Official Tapped as Hamburg Advisor

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Former National Restaurant Association chief administrative officer Molly Varney Muldoon joins FDA as commissioner Margaret Hambur...

FDA OKs Aurobindo Generic Zyrtec Syrup

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FDA gives final approval to Aurobindo Pharma for cetirizine hydrochloride syrup 1mg/mL, a generic copy of McNeil Consumer Healthca...

Advisors Vote 9-8 for Hexvix

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FDAs Oncologic Drugs Advisory Committee recommends 9-8 that FDA approve Photocures Hexvix bladder cancer imaging drug.

Keryx Biopharmaceuticals Opens a Phase 3 Perifosine Trial

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Keryx Biopharmaceuticals opens a Phase 3 trial of perifosine in relapsed and refractory multiple myeloma patients.

FDA Clears Agendias MammaPrint for All Ages

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FDA clears an Agendia 510(k) for the MammaPrint breast cancer recurrence test that broadens its use to women of all ages.

FDA OKs Elanco sNADA for Swine Feed

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Federal Register Final rule: FDA approves an Elanco Animal Health sNADA for using two-way combination swine feeds formulated with ...

ICH Guidance on Safety of Biotechnology-Derived Pharmaceuticals

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Federal Register Notice: FDA releases an ICH draft guidance, Addendum to ICH S6: Preclinical Safety Evaluation of Biotechnology-De...

CDRH Seeks Predictability in Applying New Science to Decisions

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CDRH schedules a public meeting at which to receive input on how it can better adapt to using new science in regulatory decisions.

Drug Companies Cutting Sales Staffs

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Reuters reports that many drug companies in the U.S. and Europe are cutting the number of sales reps as doctors lose influence ove...

ICH Guidance on Capillary Electrophoresis

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Federal Register Notice: FDA releases an ICH draft guidance, Q4B Evaluation and Recommendation of Pharmacopeial Texts for Use in t...