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Reauthorization of the Prescription Drug User Fee Act (PDUFA)

Apr 12 2010
BIO's comments support the reauthorization of PDUFA and discuss how to ensure achievement of the goals envisioned as well as considering what refinements might be made in order to achieve those goals.

Clear, consistent and open communication with the public and regulated industry, conducted in a manner that balances the importance of protecting competitive commercial information, is a critical FDA function.

Apr 9 2010

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BIO Letters of Support for Funding for the Cures Acceleration Network (CAN)

Apr 7 2010

Letters expressing support for $500 million in funding for CAN for FY2011.

BIO Policy Statement: Options for Increasing Access to Medicines in the Developing World

Apr 1 2010
Biotechnology plays a critical role in saving lives and improving the quality of life for millions of people throughout the world. It provides useful tools for combating disease, hunger, climate change, and other environmental impacts. The Biotechnology Industry Organization (BIO) is committed to addressing these global changes. BIO represents biotechnology companies, academic institutions, state biotechnology centers, venture capital firms, and related organizations throughout the United States and in 30 countries.   

Draft Guidance on Assessment of Abuse Potential of Drugs

Mar 29 2010

Cellulosic Biofuel: BIO Asks Congress to Fund Reverse Auction

Mar 23 2010

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BIO Priorities in FY2011 Labor, Health and Human Services, Education and Related Agencies Appropriations Act

Mar 23 2010

Letters urging funding for public health programs and initiatives which utilize biotechnology to help meet our nation’s unmet medical needs.

BIO comments to the Office of Management and Budget regarding "Introduction of Organisms and Products Altered or Produced Through Genetic Engineering"

Mar 23 2010

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Draft Guidance on IRB Continuing Review After Clinical Investigation Approval

Mar 15 2010

BIO's comments regarding Inclusion of TRICARE Retail Pharmacy Program in Federal Procurement of Pharmaceuticals

Mar 11 2010