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BIO Submits Comments to FDA on "Draft Guidance for Industry on Medication Guides—Distribution Requirements and Inclusion of Medication Guides in Risk Evaluation and Mitigation Strategies"

May 31 2011

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BIO Submits "Guideline on immunogenicity assessment of monoclonal antibodies intended for in vivo clinical use" Comments to the European Medicines Agency (EMA)

May 31 2011

BIO Submits "Guideline on immunogenicity assessment of monoclonal antibodies intended for in vivo clinical use" Comments to the European Medicines Agency (EMA)

May 31 2011

BIO provides specific comments and requests clarifications on the text of the Guideline regarding the variability of immunogenicity, approaches for predicting and reducing immunogenicity,...

Driving Innovation and Job Growth Through the Life Sciences Industry

May 25 2011

Driving Innovation and Job Growth Through the Life Sciences Industry

May 25 2011
Representatives of the bioscience industry testified before the U.S. Congress Joint Economic Committee today, as part of a hearing entitled Driving Innovation and Job Growth through the Life Sciences Industry.

BIO Urges Congress to Reauthorize Pendemic and All-Hazards Preparedness Act

May 17 2011
In testimony before the Senate Health, Education, Labor and Pensions Committee, BIO urged lawmakers to reauthorize the Pandemic and All-Hazards Preparedness Act and suggested that changes be made to encourage more industry participation in the development of medical countermeasures. Greater transparency and clarity in the medical countermeasure market establishment, the contracting administration process, and in advanced research and development activities is essential.

Biofuels: Congress Should Maintain Renewable Fuel Standard, BIO and Other Groups Urge (May 17, 2011)

May 17 2011
The federal Renewable Fuel Standard provides the stable policy essential to attracting private investment to the development of advanced biofuels, argue BIO and other biofuel advocacy groups in a letter to Congressional leaders.

BIO Requests for FY 2012 Energy and Water Appropriations Act

May 17 2011
BIO encourages Congress to support advanced biofuels and biobased products programs and initiatives during consideration of the Fiscal Year 2012 Energy & Water Appropriations bill. Industrial biotechnology is the key enabling technology that is causing a dramatic paradigm shift in the production of fuels and chemicals. By building modern biorefineries and using industrial biotechnology our nation could significantly reduce its dependence on foreign sources of oil.

BIO Commends Department of Commerce for Promoting Robust Intellectual Property Standards and Policies Abroad

May 13 2011
BIO joined the Pharmaceutical Research and Manufacturers of America (PhRMA) in a letter commending Department of Commerce Secretary Gary Locke for his leadership in promoting robust intellectual property standards and policies. The letter commends the United States Patent Office (PTO) for their engagement at the World Intellectual Property Organization (WIPO) resisting calls to commence negotiations on ill-advised and harmful changes to the global patent system relating to "genetic resources" and "traditional knowledge."

BIO Requests for FY 2012 Agriculture, Rural Development, FDA and Related Agencies Appropriations Act

May 12 2011
BIO respectfully supports the Administration's request for a total of $2.744 billion in budget authority for the FDA and support robust funding for key programs within the U.S. Department of Agriculture.