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BIO's Comment on Advanced Notice of Proposed Rulemaking Regarding Review of Controls for Certain Emerging Technologies

BIO urges the Administration to fully assess the potential impact of export controls on biotechnologies on “the impact on the economy of the United States” and on the sustainability of the U.S....

BIO Statement on China Approvals of Agricultural Biotechnology Products

Biotechnology Innovation Organization (BIO) President and CEO Jim Greenwood issued the following statement on the announcement that the People’s Republic of China’s National Biosafety Committee approved the final safety certificate for five agricultural biotechnology products.

New Platform for Innovation in Food and Agriculture Launches, Invites Broad Conversation

WASHINGTON, DC – Jan. 16, 2019 – Today, the Biotechnology Innovation Organization (BIO) and the American Seed Trade Association (ASTA) jointly announce the launch of Innovature, a new platform to spark a thoughtful dialogue around innovation in food and agriculture, with an initial focus on gene editing. Growing understanding of gene editing is spurring new developments in food and agriculture to address some of our most pressing societal challenges.

BIO's Comments on the Expanded CFIUS Review Pilot Program

Comment letter to Treasury on the CFIUS pilot program 

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

“Members of the House have sent a strong signal to the American people about their commitment to prioritizing health security by providing the resources needed to fully prepare for and defend against biological threats. Strengthening the pipeline of medical products, drugs and devices that will safeguard the nation during an emergency or pandemic is vital to our national security."

Proppant Express Investments vs. Oren Technologies (BIO Brief as Amicus Curiae)

BIO files an Amicus Brief on rehearing by the Precedential Opinion Panel of the Patent Trial and Appeal Board.

BIO Comments on FDA Draft Guidance Rare Diseases: Early Drug Development and the Role of Pre-IND Meetings

December 17, 2019

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PFDD: BIO Comments on 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, 2019

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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.