EPA: Greenhouse Gas ("GHG") Emissions from Biogenic Sources

Jun 13 2010
BIO says that EPA should take account of the fundamental difference between combustion of fossil fuels and combustion of biofuels and other bioenergy sources made from renewable biomass.

Drug Importation: Statement of Opposition to S. 6210-A (Diaz)/A. 9207-A (Crespo) addressed to the Senate Finance Committee of New York State

Jun 7 2010
BIO Opposes an initiative to permit the purchase of certain prescription medications from Canadian mail order pharmacies by New York civil service employees and retirees. BIO believes that, at bottom, even a narrowly-tailored importation program with reasonable oversight cannot adequately ensure the safety and efficacy of all of the products available to residents from these pharmacies.

USDA: Solicitation of Input from Stakeholders Regarding Agriculture and Food Research Initiative (AFRI)

Jun 7 2010


Farm Bill: Biofuels Groups Urge Continued Funding for Energy Title

Jun 1 2010
BIO and 18 other renewable energy proponents write to leaders of Senate Appropriations Committee asking that Farm Bill energy programs be reauthorized for FY 2011.

Intellectual Property: New Mechanism for Deferring the Filing a Complete Patent Application if a Previous Provisional Patent Application was Filed and is Relied on by the Applicant

Jun 1 2010

BIO questions about the utility and expected impact of the proposal, and why patent applicants should be debited with subtractions from otherwise available patent term extension.

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Clinical Trials: BIO Comments to FDA on Draft Guidance on Non-Inferiority Clinical Trials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


Clinical Trials: BIO Submits Comments on the Draft Guidance for Industry on Adaptive Design Clinical Trials for Drugs and Biologics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