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James C. Stansel Sidley Austin LLP

Results 1 to 5 of 73



OIG updates provider self-disclosure protocol *

USA - April 19 2013
On April 17, 2013, the Department of Health and Human Services' Office of Inspector General ("OIG") released an Updated Provider Self-Disclosure…

Co-authors: Mark B. Langdon.


China develops new rules to simplify medical device re-registration process *

China - April 1 2013
China's newly restructured food and drug regulatory agency, the China Food and Drug Administration ("CFDA"), has published new draft rules to…

Co-authors: Paul E. Kalb, M.D, Scott Bass, David J. Zampa, M. Patricia Thayer, Michael W. Davis.


SFDA 2012 Anual Drug Review Report highlights innovator focus *

China - March 8 2013
On February 28, 2013, the Center for Drug Evaluation of the State Foodand Drug Administration ("CDE"), the key agency reviewing safety andefficacy…

Co-authors: Scott Bass.


FDA finalizes guidance to address potential bias and conflicts of interest in clinical investigations *

USA - March 1 2013
FDA has finalized its guidance on financial disclosure for clinical investigators. A draft of the guidance, published in May 2011, was developed in…

Co-authors: Scott Bass, Raymond A. Bonner, Coleen Klasmeier.


Top 10 steps global life sciences companies should take in 2013 *

USA - March 1 2013
Engage in US budget and deficit reduction process. As governments, including the US and China, search for the means to fund priorities or reduce…

Co-authors: Paul E. Kalb, M.D, Scott Bass, David J. Zampa, M. Patricia Thayer, Michael W. Davis.


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