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FDA, Rare Diseases, Orphan Drug Act: Food and Drug Administration Review and Regulation of Articles for the Treatment of Rare Diseases

May 31 2010
BIO’s final comments on Considerations Regarding Food and Drug Administration Review and Regulation of Articles for the Treatment of Rare Diseases.

Clinical Trials: BIO Comments to FDA on Draft Guidance on Non-Inferiority Clinical Trials

May 27 2010

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Clinical Trials: BIO Submits Comments on the Draft Guidance for Industry on Adaptive Design Clinical Trials for Drugs and Biologics

May 27 2010
BIO’s comments recommend that the guidance address adaptation methods, and statistical and logistical considerations for using adaptive designs in exploratory studies, in addition to those for adequate and well-controlled studies. The comments also propose that the guidance provide a stand-alone section addressing methods, trial logistics, documentation, and interactions with the FDA for exploratory studies.

Bayh-Dole: Access to Early Capital Paper

May 27 2010
The paper highlights factors that contribute to enabling environments for promising technologies to gain access to early capital.

Technology Transfer: BIO Comments to Office of Science and Technology Policy on Commercialization of University Research

May 25 2010
The Biotechnology industry Organization appreciates the opportunity to respond to the Request for Information issued by the Office of Science and Technology Policy and the National Economic Council on Commercialization of University Research.

Bayh-Dole: BIO Comments to Office of Science and Technology Policy on Commercialization of University Research

May 25 2010

FDA: Proposed Rule: Reporting Information Regarding Falsification of Data

May 20 2010

GREEN JOBS: Act Would Extend Cellulosic Biofuel Tax Credits, Make Algae Eligible

May 17 2010

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Medicare: Comments on the Medicare Coverage Gap Discount Program Beginning in 2011

May 14 2010
BIO supports the coverage gap discount program and believes that it will increase patient access to life-saving and life enhancing therapies.

Jim Greenwood's Address at the 2010 BIO International Convention

May 5 2010