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Michael J. Werner Holland & Knight LLP

Results 1 to 5 of 11



Controversial U.S. medical study raises informed consent questions *

USA - May 9 2013
The recent controversy surrounding a study of newborn babies in universities across the United States demonstrates the importance of compliance with…


CMS issues final Physician Payment Sunshine Rule *

USA - February 4 2013
In an action that will have broad implications for drug and device manufacturers, researchers, distributors, teaching hospitals and physicians, on…


Congress enacts sweeping FDA reforms *

USA - June 27 2012
With a final overwhelming vote in the Senate, the U.S. Congress passed an FDA user fee bill that will provide necessary funds for the agency to perform drug reviews and require it to meet performance goals, as well as other important reforms.


Congress on the verge of enacting sweeping FDA reforms *

USA - May 30 2012
The U.S. House of Representatives today is expected to pass its version of the Prescription Drug User Fee Act by an overwhelming majority.


Congress acts to speed FDA drug reviews *

USA - March 20 2012
Congress is taking steps to ensure that drugs and biological products reach the market sooner.


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