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New Study: Biofuel Use Saved 589.3 Million Tons of Carbon Emissions Over the Past Decade

At its tenth anniversary, the Renewable Fuel Standard's requirement to substitute biofuels for fossil fuels has displaced nearly 1.9 billion barrels of foreign oil and reduced associated carbon emissions by 589.3 million metric tons.

Statement Regarding the USPTO Proposed IPR Rule Amendments

BIO issued a statement regarding the United States Patent and Trademark Office’s (PTO) proposed changes to the rules governing the Patent Trial and Appeal Board (PTAB) inter partes review (IPR) proceedings...

BIO Submits Comments on Patient Preference Information

The Biotechnology Industry Organization (BIO) thanks the Food and Drug Administration (FDA) for the opportunity to submit comments on the Draft Guidance for Industry, FDA Staff and Other Stakeholders entitled “Patient Preference Information – Submission, Review in PMAs, HDE Applications, and De Novo Requests, and Inclusion in Device Labeling.”

14th Annual BIO Investor Forum to Celebrate Fierce 15 Winners amid Rising Investor Interest in Biotechnology

BIO Investor Forum to be held October 20-21 in San Francisco, California  

BIO Submits Comments on Male-Mediated Developmental Risk

The Biotechnology Industry Organization (BIO) thanks the Food and Drug Administration (FDA) for the opportunity to submit comments on the Draft Guidance for Industry on Assessment of Male-Mediated Developmental Risk for Pharmaceuticals.

BIO Names Jeanne Haggerty as Senior Vice President for Federal Government Relations

BIO announced the appointment of Jeanne Haggerty as Senior Vice President of Federal Government Relations.

BIO Comments on Established Conditions Reportable CMC Changes

The Biotechnology Industry Organization (BIO) thanks the Food and Drug Administration (FDA) for the opportunity to submit comments on the “Draft Guidance on Established Conditions: Reportable CMC Changes for Approved Drug and Biologic Products” (“Draft Guidance”).

BIO Comments on Established Conditions Reportable CMC Changes

The Biotechnology Industry Organization (BIO) thanks the Food and Drug Administration (FDA) for the opportunity to submit comments on the “Draft Guidance on Established Conditions: Reportable CMC Changes for Approved Drug and Biologic Products” (“Draft Guidance”).

BIO Applauds Bipartisan Legislation That Levels the Playing Field for Renewable Chemicals

BIO expresses thanks to Representatives Bill Pascrell (D-N.J.), Mike Fitzpatrick (R-PA), and Richard Neal (D-MA) for introducing, H.R. 3390, which provides renewable chemical producers access to production or investment tax credits currently available to other renewable energy producers.

BIO Joins Coalition Cautioning Against Further Restructuring of Japan’s Pharmaceutical Pricing Structure

Today BIO joined a coalition of organizations urging the Government of Japan to maintain the established reimbursement pricing structure for pharmaceuticals and medical devices.