BIO urges EPA to get the RFS back on track with a commitment to stable implementation of the program that tracks statutory requirements. In particular, we urge EPA to account more appropriately for the availability of advanced and other biofuels to meet statutory volume requirements, and to make…
Letters, Testimony & Comments | September 26, 2016
Why the focus on intellectual property fails to address the complexities of medicinal access in IndiaStephen M. Sammut and Daniel S. LevineReleased in San Francisco, June, 2016Supported by and prepared for the Biotechnology Innovation Organization and the Association of Biotechnology Led…
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…
Re: Docket No. FDA–2016–D–2268: Insanitary Conditions at Compounding Facilities; Draft Guidance for Industry; Availability Dear Sir/Madam: The Biotechnology Innovation Organization (BIO) thanks the Food and Drug Administration (FDA) for the opportunity to submit comments on the Draft…
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Copies of a Commercially Available Drug Product Under Section 503A of the Federal Food, Drug, and Cosmetic Act; Draft Guidance for Industry; andFDA-2016-D-1267: Compounded Drug Products That Are Essentially Copies of…
Re: Docket No. FDA-2016-D-1703Dear Sir/Madam:The Biotechnology Innovation Organization (BIO) thanks the Food and Drug Administration (FDA) for the opportunity to submit comments on the “Principles for Codevelopment of an In Vitro Companion Diagnostic Device with a Therapeutic Product; Draft…
BIO issued a letter to Congressional Leadership, the Senate Finance Committee Chairs, and the House Ways and Means Committee Chairs calling for the extension of renewable energy tax credits slated to expire at the end of 2016. In its letter, BIO urges Congress to advance a multi-year extension of…
BIO is pleased to submit these comments in response to the Notice of Request for Public Comment published by the National Science and Technology Council, Science and Technology Policy Office. The Coordinated Framework for Regulation of Biotechnology (Coordinated Framework) has made it possible…
Re: Docket No. FDA–2016–N–2673: Public Meeting on Progress Toward Implementing the Product Identification Requirements of the Drug Supply Chain Security Act Dear Sir/Madam: The Biotechnology Innovation Organization (BIO) thanks the Food and Drug Administration (FDA) for the opportunity to…