European Commission proposed overhaul of EU clinical trials legislation *

European Union - July 30 2012
On July 17, 2012 the European Commission adopted a proposal to reform the existing EU clinical trials regulatory framework.

Co-authors: Héctor Armengod, J. Benneville (Ben) Haas.

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The Food and Drug Administration Safety and Innovation Act of 2012: assessing the impact on the medical device industry *

USA - July 17 2012
On July 9, 2012, President Obama signed the Food and Drug Administration Safety and Innovation Act of 2012 (FDASIA) into law.

Co-authors: John R. Manthei, Rebecca N. Brandt.

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The Food and Drug Administration Safety and Innovation Act of 2012: assessing the impact on the pharmaceutical and biotechnology industries *

USA - July 16 2012
On July 9, 2012, President Obama signed the Food and Drug Administration Safety and Innovation Act of 2012 (FDASIA) into law.

Co-authors: John R. Manthei, Rebecca N. Brandt.

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Medical device benefit-risk determinations: FDA releases a novel guidance giving industry an inside view of agency decision-making *

USA - April 12 2012
On March 27, 2012, the Food and Drug Administration (FDA or Agency) released a final guidance describing the principal factors the it considers when making benefit-risk determinations in the medical device premarket review process.

Co-authors: J. Benneville (Ben) Haas, Elizabeth M. Richards.

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Opening the door for generic biologics: FDA releases the first guidance documents implementing the biosimilar approval pathway *

USA - February 16 2012
Therapeutic biologic products are at the forefront of medical research and provide promising treatments for a variety of medical conditions.

Co-authors: John R. Manthei, Carolyne R. Hathaway.

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