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BIO Comments on FDA Draft Guidance on Good Review Management Principles and Practices for New Drug Applications and Biologics License Applications

December 18, 2019

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Advance Notice of Proposed Rulemaking: International Pricing Index Model for Medicare Part B Drugs

BIO strongly opposes the potential proposal detailed in the Advance Notice of Proposed Rulemaking (ANPRM) on the International Pricing Index (IPI) and calls for withdrawal of the IPI model in its entirety.

BIO Applauds House Passage of the Pandemic and All-Hazards Preparedness and Advancing Innovation Act

Washington, DC (December 20, 2018) – Biotechnology Innovation Organization (BIO) President and CEO Jim Greenwood issued the following statement applauding passage today by the House of Representatives of the Pandemic and All-Hazards Preparedness and Advancing Innovation Act of 2018 (H.R. 7328). The legislation would re-authorize critical federal biodefense programs and agencies, including the BioShield Special Reserve Fund (SRF), the Biomedical Advanced Research and Development Authority (BARDA), and the Strategic National Stockpile (SNS).

BIO Letter to POTUS on U.S./China Trade

The following letter was sent to the President of the United States in response to talks between the U.S. and China related to trade. 

BIO Statement on USDA Finalizing Rule for National Bioengineered Food Disclosure Standard

The Biotechnology Innovation Organization today released the following statement in response to USDA issuing a final rule implementing the National Bioengineered Food Disclosure Standard:  

Heading East: Biopharma International Expansion to China and Asia

This Special Report highlights the potential opportunities, entry approaches and local partner selection, and also include recommendations on market acceleration and internationalization.

BIO Statement on Hatch-Waxman Integrity Act of 2018

“For almost 40 years, the groundbreaking law known as the Hatch-Waxman Act (HWA) has been highly successful in spurring the development of life-saving new treatments while at the same time vastly broadening the availability of low-cost generic pharmaceuticals."

PFDD: Patient-Focused Drug Development Guidance: Methods to Identify What Is Important to Patients and Select, Develop, or Modify Fit-for-Purpose Clinical Outcome Assessments

December 14, 2018

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BIO Comments on USTR Objectives for U.S. – Japan Trade Agreement

BIO supports the U.S. government entering negotiations with the Government of Japan as an opportunity to grow U.S. exports and create U.S. jobs. 

ICH Q12: BIO Comments on ICH Q12 Draft Guideline

December 12, 2018

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