• David Nachmansohn, Nerve Gases and Electric Eels

    23 September 2016

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CDSCO Advances Draft Medical Device Rules, Outlines Fees

26 September 2016

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EMA and FDA Set Up New Working Group on Rare Diseases

26 September 2016

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Biomarkers Used as Outcomes: FDA Wants to Hear More on Examples

26 September 2016

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GDUFA II: FDA Looks to Speed Up Generic Drug Approval Process

26 September 2016

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Regulatory Recon: Pfizer Decides Not to Split; Regeneron Gets Priority Review for Eczema Drug (26 September 2016)

26 September 2016

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FDA Approves First Humira Biosimilar

23 September 2016

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ISO 13485: Ex-FDA Official Kim Trautman Gives Advice on Transitioning

23 September 2016

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Regulatory Recon: States Allege Indivior Tried to Block Generic Competition for Suboxone; Novartis' Zykadia Successful in Lung Cancer Phase III (23 September 2016)

23 September 2016

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Regulatory Recon: FDA’s Califf Calls for Sarepta Trial Retraction; Alzheimer’s Drug Fails in Phase III Study (22 September 2016)

22 September 2016

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FDA May Push Back Release of Biosimilar Interchangeability Draft Guidance

22 September 2016

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