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Letters, Testimony & Comments

BIO submits letters, testimony, and comments to government and regulatory bodies throughout the United States and around the world.

Featured Letters, Testimony, & Comments
BIO Letter to HRSA on 340B Rebate Model
Under the 340B program, participating manufacturers must offer 340B pricing on their covered outpatient drugs by covered entities, as a condition of having those drugs federally payable under Medicare Part B and Medicaid. Critically, Congress…
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CSBA Letter to Congressional Leadership on…
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BIO Comments to the USPTO’s MAY 10, 2024 Proposed…
BIO submitted these comments in response to the United States Patent and Trademark Office’s May 10, 2024, Notice of Proposed Rulemaking regarding Terminal Disclaimer Practice to Obviate Nonstatutory Double Patenting.
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DSCSA: BIO Submits Comments to FDA's Public Meeting on Progress Toward Implementing the Product Identification Requirements of the Drug Supply Chain Security Act
November 23, 2016
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…
BIO Position on Proposals to Provide for Export Manufacturing Exemption during Patent Term Restoration
November 18, 2016
Export manufacturing exemptions weaken the IP protections afforded by Supplementary Protection Certificate and Patent Term Restoration.
BIO Submits Comments in Reponse to the Notice of a Request for Information re Clarifying Current Roles and Responsibilities Described in the Coordinated Framework for the Regulation of Biotechnology
November 2, 2016
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…
October 2016 BIO Letter to Congress re Bioenergy Tax Credits
October 18, 2016
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…
Codevelopment: BIO Comments on FDA Draft Guidance Principles for Codevelopment of an In Vitro Companion Diagnostic Device with a Therapeutic Product
October 13, 2016
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…
Compounding: BIO Comments on FDA Draft Guidances on "Essentially Copies"
October 13, 2016
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…
Compounding: BIO Comments on FDA Draft Guidance nsanitary Conditions at Compounding Facilities
October 6, 2016
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…
Support House Ag Biotech Education Funding
October 6, 2016
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…
Neat, Plausible, and Wrong
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…
BIO Submits Comments in Response to the OSTP's RFI on the Coordinated Framework for the Regulation of Biotechnology Products
September 16, 2016
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…