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Clinical Trials: BIO Comments on FDA Draft Guidance Enhancing the Diversity of Clinical Trial Populations-Eligibility Criteria, Enrollment Practices, and Trial Designs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Organization (BIO) thanks the Food and Drug Administration (FDA) for the opportunity to submit comments on the Draft Guidance titled Enhancing the Diversity of Clinical Trial Populations-Eligibility Criteria, Enrollment Practices, and Trial Designs.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

Senate Finance Drug Pricing Proposal Misses the Mark

“While we’re pleased that the Senate Finance Committee proposal caps what beneficiaries have to pay out of pocket for medicines under Medicare Part D, it adopts a framework that punishes some of the most innovative biotech cures and transformative therapies." 

Increased Investment in Research for Debilitating Diseases is Focus of Newly Introduced Bill in Congress Today

Legislation would significantly improve the ability of emerging biotechnology companies to focus their investor capital on science and biomedical innovation was introduced in the House of Representatives by Reps. Trey Hollingsworth (R-IN) and Ben McAdams (D-UT). The Fostering Innovation Act extends one vital JOBS Act provision – the temporary exemption from Section 404(b) of Sarbanes-Oxley (SOX) – for an additional five years for qualifying pre-revenue small businesses.

Biosimilars: BIO Comments on FDA Draft Guidance : Development of Therapeutic Protein Biosimilars: Comparative Analytical Assessment and Other Quality-Related Considerations

The Biotechnology Innovation Organization (BIO) thanks the Food and Drug Administration (FDA) for the opportunity to submit comments on the Draft Guidance titled Development of Therapeutic Protein Biosimilars: Comparative Analytical Assessment and Other Quality-Related Considerations.

Pediatrics: BIO Comments on FDA Draft Guidance Postapproval Pregnancy Safety Studies

The Biotechnology Innovation Organization (BIO) thanks the Food and Drug Administration (FDA or Agency) for the opportunity to submit comments to the Draft Guidance on Postapproval Pregnancy Safety Studies.

BIO World Congress Showcases Green Solutions to Address Global Challenges

As presidential candidates trek across the Hawkeye State and campaign on addressing society’s most pressing challenges, biotech innovators wrapped up four days of showcasing the scientific solutions to climate change, hunger, pollution and energy security.