Carol Pratt, Ph.D.

Carol Pratt, Ph.D.

K&L Gates LLP

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Sharing Clinical Trial Data: A New Era in Life Sciences Has Begun

The European Medicine Agency’s (EMA) Policy on Publication of Clinical Data for Medicinal Products for Human Use (“EMA Policy”)is now effective as of January 1, 2015. Across the Atlantic, the U.S. Institute of Medicine (IOM)...more

3/25/2015 - Clinical Trials Data-Sharing EU HHS Life Sciences NIH

Global Food, Drug and Medical Device Newsletter

In this issue: Legislative Updates: - (i) USA - (ii) EU - (iii) China - (iv) Australia - (v) Japan. - Featured Articles: - (i) Caffeinated Energy Drinks - a Global Perspective - (ii)...more

10/10/2013 - Advertising Animal Testing Australia Cosmetics Energy Drinks EU Food Labeling FTC Health Claims Japan Medical Devices Personally Identifiable Information POM Wonderful

Funding Said Top Medical Research Area In 2013; Common Rule, COI Also Make List

Originally published in Medical Research Law & Policy Report, 12 MRLR 4, 01/02/2013. Regardless of what happens with the fiscal cliff negotiations in Congress and the Obama administration, research funding will...more

1/7/2013 - Audits DNA Electronic Medical Records Enforcement FDA Personalized Medicine Privacy Policy Research Funding Sunshine Act

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