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Thiel associate Srinivasan reportedly considered for FDA chief

FDLI SmartBrief | Jan 17, 2017

Former biotech executive Balaji Srinivasan, an associate of venture capitalist Peter Thiel, is under consideration by President-elect Donald Trump to head the FDA, sources say. Srinivasan has been critical of the FDA, saying it has slowed scientific innovation. Bloomberg (01/13) The Hindu (India) (01/17)


Eisai receives FDA Form 483 over quality control issues

FDLI SmartBrief | Jan 13, 2017

FDA: Cancer patients should not use PNC-27

FDLI SmartBrief | Jan 12, 2017

FDA finalizes guidance on naming of biologics and biosimilars

FDLI SmartBrief | Jan 13, 2017

Timing rule for biosimilar launches under Supreme Court review

FDLI SmartBrief | Jan 16, 2017

Draft guidance released by FDA to speed up generics approvals, clear up terms

FDLI SmartBrief | Jan 16, 2017

FDA publishes guidances on drug and biologics repackaging, mixing, diluting

FDLI SmartBrief | Jan 17, 2017

Final guidance on benefit-risk determinations for IDEs issued by FDA

FDLI SmartBrief | Jan 13, 2017

Final rule on tobacco use in medical applications clarified by FDA

FDLI SmartBrief | Jan 16, 2017

Tesaro's nausea and vomiting drug turned down by FDA

FDLI SmartBrief | Jan 13, 2017


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Annual Conference breakout topics announced -- register by Jan. 31 and SAVE!

FDLI SmartBrief | Jan 18, 2017

Taking place in April: Introduction to US Drug Law and Regulation

FDLI SmartBrief | Jan 18, 2017

Taking place in April: Introduction to U.S. Medical Device Law and Regulation

FDLI SmartBrief | Jan 17, 2017

FDCA Statutory Supplement, 2017: Reserve your copy today

FDLI SmartBrief | Jan 17, 2017

2017 Annual Conference Planning Committee

FDLI SmartBrief | Jan 16, 2017




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