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FDA Workshop on Developing Drugs for Serious Infections

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FDA plans a public workshop on the clinical development of drugs for preventing serious infections caused by Staphylococcus aureus...

B. Braun Medical Parenteral Nutrition Product Approved

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B. Braun Medical gains FDA approval for Nutrilipid 20% (I.V. fat emulsion) for parenteral nutrition therapy in adult and pediatric...

Kapvay Phone Script False or Misleading: OPDP

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CDERs Office of Prescription Drug Promotion notifies Concordia that a professional telephone script for its Kapvay omits important...

Clinical Pharmacology Guidance

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FDA issues a draft guidance revising a 2009 predecessor on clinical pharmacology labeling for human drug products.

Innovation Needed in Clinical Trial Design: Miller

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Former FDAer Henry Miller says changes should be made to clinical trial design and statistical analyses to better achieve personal...

CDRH Draft Guidance on De Novo Process

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CDRH posts a draft guidance on the De Novo Classification Process (Evaluation of Automatic Class 3 Designation).

AstraZeneca Reports Positive Phase 3 Results in Gout

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AstraZeneca reports that three Phase 3 clinical trials evaluating lesinurad as a combination therapy, met primary endpoints in tre...

Agios Gets FDA Fast Track for Leukemia Drug

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FDA grants fast track designation to Agios Pharmaceuticals for its first-in-class IDH2 mutant inhibitor AG-221 for treating patien...

Advisors to Discuss Spiriva Respimat for COPD

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CDER says the Pulmonary-Allergy Drugs Advisory Committee will look at potential safety concerns with Boeheringer-Ingelheim's Spiri...

Guidance on Immunogenicity Assessment for Protein Products

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FDA posts a guidance on Immunogenicity Assessment for Therapeutic Protein Products that outlines and recommends adoption of a risk...