Codevelopment: BIO Comments on FDA Draft Guidance Principles for Codevelopment of an In Vitro Companion Diagnostic Device with a Therapeutic Product

Re: Docket No. FDA-2016-D-1703


Compounding: BIO Comments on FDA Draft Guidances on "Essentially Copies"

Re: Docket No. FDA-2016-D-1309: Compounded Drug Products That Are Essentially Copies of a Commercially Available Drug Product Under Section 503A of the Federal Food, Drug, and Cosmetic Act;...

Compounding: BIO Comments on FDA Draft Guidance nsanitary Conditions at Compounding Facilities

Re: Docket No. FDA–2016–D–2268: Insanitary Conditions at Compounding Facilities; Draft Guidance for Industry; Availability ...

Support House Ag Biotech Education Funding

The undersigned organizations support the inclusion of $3 million within the Fiscal Year 2017 Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act to better inform the public about the application of biotechnology to food and agricultural production...

New BIO Report Dispels the Myth of the Blend Wall and High RIN Prices

Data recently released by EPA on compliance with the Renewable Fuel Standard between 2010 and 2013 (the latest year for which compliance is complete) challenges the widely accepted assumption that the blend wall – the point at which ethanol blending in gasoline exceeds 10 percent – caused the 2013 spike in Renewable Identification Number (RIN) spot market prices.

Neat, Plausible, and Wrong

Why the focus on intellectual property fails to address the complexities of medicinal access in India Stephen M. Sammut and Daniel S. Levine Released in San Francisco, June, 2016 Supported by and prepared for the Biotechnology Innovation Organization and the Association of Biotechnology Led Enterprises The opinions expressed in this paper are those of the authors and do not necessarily reflect the opinions of BIO and ABLE.

BIO Statement on Biosimilar User Fee Act Goals Letter

Washington, D.C. (September 16, 2016) – Biotechnology Innovation Organization (BIO) Senior Vice President for Science Policy Kay Holcombe released the following statement today regarding the Biosimilar User Fee Act (BsUFA) II goals letter:

BIO Applauds Senate Passage of Advancing Hope Act

Washington, D.C. (September 23, 2016) – Biotechnology Innovation Organization (BIO) President and CEO Jim Greenwood released the following statement today regarding Senate passage of the Advancing Hope Act of 2016:

BIO Submits Comments in Response to the OSTP's RFI on the Coordinated Framework for the Regulation of Biotechnology Products

BIO submits comments to submits comments in response to the Notice of a Request for Information, published by the National Science and Technology Council, Science and Technology Policy Office. Comments were submitted to Food and Drug Administration Docket No. FDA-2015-N-3403; Clarifying Current Roles and Responsibilities Described in the Coordinated Framework for the Regulation of Biotechnology and Developing a Long-Term Strategy for the Regulation of the Products of Biotechnology.

BIO AFBF GE Salmon Labeling Provision Letter

The Biotechnology Innovation Organization along with the American Farm Bureau Federation sent a letter to the House of Representatives and Senate Appropriations Committees urging the Committees to oppose any provision related to bioengineered food labeling, including salmon labeling, that may come up for consideration during the Fiscal Year 2017 appropriations process.