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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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BIO Submits Comments Re: Hospital Outpatient Prospective Payment and Ambulatory Surgical Center Payment Systems (OPPS) and Quality Reporting Programs Proposed Rule
October 21, 2019
Dear Administrator Verma,The Biotechnology Innovation Organization (BIO) appreciates the opportunity to comment onthe Centers for Medicare & Medicaid Services’ (CMS’) Medicare Hospital OutpatientProspective Payment and Ambulatory Surgical Center…
Pediatrics: BIO Comments on FDA Draft Guidance on Rare Pediatric Priority Review Vouchers
October 2, 2019
September 30, 2019Re: Docket No. FDA–2014-D-1461: FDA Draft Guidance, Rare Pediatric Priority Review Vouchers.Dear Sir/Madam:The Biotechnology Innovation Organization (BIO) thanks the Food and Drug Administration (FDA or Agency) for the opportunity…
ICH: BIO Comments on ICH E8(R1) General Considerations for Clinical Studies
September 30, 2019
September 30, 2019Re: Docket ID FDA-2019-D-3049: E8(R1) General Considerations for Clinical Studies; International Council for HarmonisationDear Sir/Madam:The Biotechnology Innovation Organization (BIO) thanks the Food and Drug Administration (FDA)…
BIO Comments on FDA Draft Guidance on ICH E19 Optimization of Safety Data Collection
September 27, 2019
BIO submitted comments to the Food and Drug Administration (FDA) on E19 Optimisation of Safety Data Collection; International Council for Harmonisation. BIO welcomes this document on the optimization of safety data collection and supports the goal…
ICH: BIO Submits Comments on FDA Draft Guidance ICH M10 Bioanalytical Method Validation
September 25, 2019
September 25, 2019Re: FDA-2019-D-1469: M10 Bioanalytical Method Validation; International Council for Harmonisation; Draft Guidance for IndustryDear Sir/Madam:The Biotechnology Innovation Organization (BIO) thanks the Food and Drug Administration …
BIO Comments on ICER’s Value Assessment Framework for Transformative Therapies
September 6, 2019
We are writing on behalf of the Biotechnology Innovation Organization (BIO) to provide comments on the Institute for Clinical and Economic Review’s (ICER’s) solicitation for input on draft revisions to its Value Assessment Framework for the…
BIO Comments on RFS Standards for 2020 and Biomass-Based Diesel Volumes for 2021, Response to the Remand of the 2016 Standards
August 30, 2019
BIO's comments on the EPA’s administration of the of the Renewable Fuel Standard (RFS)  program and how it has put the investments made by BIO Member companies at risk and threatens to prevent growth in advanced and cellulosic biofuels as the…
BIO Submits Comments on FDA : New Drug Regulatory Program Modernization: Improving Approval Package Documentation and Communication
August 26, 2019
August 25, 2019 Re: Docket No. FDA–2019-N-2012: New Drug Regulatory Program Modernization: Improving Approval Package Documentation and Communication. Dear Sir/Madam: The Biotechnology Innovation Organization (BIO) thanks the Food and Drug…
BIO Comments on FDA Draft Guidance on Enhancing the Diversity of Clinical Trial Populations-Eligibility Criteria, Enrollment Practices, and Trial Designs
August 6, 2019
BIO submitted comments on the Food and Drug Administration (FDA) Draft Guidance, Enhancing the Diversity of Clinical Trial Populations – Eligibility Criteria, Enrollment Practices, and Trial Designs. BIO welcomes FDA’s recommendations to broaden…
BIO Comments on USDA's Proposed Part 340 Revisions
August 5, 2019
On behalf of the Biotechnology Innovation Organization (BIO), thank you for the opportunity to provide comments to the United States Department of Agriculture on its June 6, 2019 Proposed Rule regarding the movement of certain genetically engineered…