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ICH: BIO Comments on FDA Draft Guidance ICH E19 Optimisation of Safety Data Collection

September 25, 2019

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ICH: BIO Submits Comments on FDA Draft Guidance ICH M10 Bioanalytical Method Validation

September 25, 2019

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New Executive Order Critical to Protecting Patients and Public Health

President Trump has signed an executive order focused on spurring the development of new vaccine technologies, prioritizing the production of influenza vaccines and identifying strategies for communicating the importance of influenza vaccination. 

Speaker Pelosi’s Drug Pricing Plan “Crushes the Desperate Hopes of Patients and their Families”

Washington, D.C. (September 19, 2019) – Former Congressman Jim Greenwood, the President and CEO of the Biotechnology Innovation Organization (BIO), issued the following...

BIO Submits Comments on FDA : New Drug Regulatory Program Modernization: Improving Approval Package Documentation and Communication

The Biotechnology Innovation Organization (BIO) thanks the Food and Drug Administration (FDA) for the opportunity to submit comments regarding the New Drug Regulatory Modernization: Improving Approval Package Documentation and Communication.

Administration Undermines Farmers and Rural Economies With Unjustifiable Renewable Fuel Standard Waivers

Washington, D.C. (August 10, 2019) –The Biotechnology Innovation Organization (BIO) released the following statement on the administration’s decision to issue 31 small refinery exemptions under the Renewable Fuel Standard.

Clinical Trials: BIO Comments on FDA Draft Guidance Enhancing the Diversity of Clinical Trial Populations-Eligibility Criteria, Enrollment Practices, and Trial Designs

The Biotechnology Innovation Organization (BIO) thanks the Food and Drug Administration (FDA) for the opportunity to submit comments on the Draft Guidance titled Enhancing the Diversity of Clinical Trial Populations-Eligibility Criteria, Enrollment Practices, and Trial Designs.

BIO Proposes Greater Public Access to Information on New Agricultural Biotechnology Products

The Biotechnology Innovation Organization (BIO) today put forward a consumer-friendly proposal that would improve public access to information about new agricultural biotechnology products. Combined with a new science-based regulatory approach, BIO’s proposal will foster greater public confidence and support bringing new sustainable agricultural solutions to the market.

HHS Drug Importation Plan a “Misguided Attempt to Keep an Ill-Informed Campaign Promise”

“There is simply no way to adopt an importation scheme that doesn’t jeopardize the health and well-being of America’s patients," BIO’s President and CEO Jim Greenwood said.

BIO Asia-Taiwan 2019 Showcased Biotech as the Region’s Next Growth Engine

Event Brought Together Biopharma Executives and Investors from Around the World for Deal Making and Partnering Opportunities