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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 Comments on EPA’s Renewables Enhancement and Growth Support (REGS) Proposed Rule
February 16, 2017
BIO supports EPA’s ongoing efforts to improve the efficiency and effectiveness of the federal Renewable Fuel Standard (“RFS”) program, which was created by Congress, with bipartisan support, in statutory provisions that President George W. Bush…
BIO Comments on FDA's Guidance on Consultation Procedures: Foods Derived from New Plant Varieties
February 9, 2017
February 9, 2017 The Biotechnology Innovation Organization (BIO) is pleased to submit these comments in response to the U.S. Food and Drug Administration’s (FDA) request for public input on a notice published in the Federal Register1 regarding…
BIO Comments on FDA's Review of Existing General Regulatory and Information Collection Requirements
February 5, 2017
February 5, 2017 The Food and Agriculture Section of the Biotechnology Innovation Organization (BIO) is pleased to submit these comments in response to the U.S. Food and Drug Administration’s (FDA) request for public input on a notice published in…
BIO Comments on FDA Draft Guidance on ANDAs for Certain Highly Purified Synthetic Peptide Drug Products Referring to Listed Drugs of rDNA Origin
February 4, 2017
BIO submitted comments on the Food and Drug Administration’s (FDA) Draft Guidance, ANDAs for Certain Highly Purified Synthetic Peptide Drug Products That Refer to Listed Drugs of rDNA Origin. BIO supports enhanced regulatory guidance on…
BIO Submits Comments on FDA proposed rule: Good Laboratory Practice for Nonclinical Laboratory Studies
January 30, 2017
RE: Docket No. FDA-2010-N-0548: The Biotechnology Innovation Organization (BIO) appreciates the opportunity to offer comments to Food and Drug Administration (FDA)’s “Good Laboratory Practice for Nonclinical Laboratory Studies.” 
BIO submits comments to Merit-Based Incentive Payment System (MIPS) and Alternative Payment Model (APM) Incentive under the Physician Fee Schedule, and Criteria for Physician-Focused Payment Models
December 23, 2016
The Biotechnology Innovation Organization appreciates the opportunity to offer comments to the final rule Medicare Program; Merit-Based Incentive Payment System (MIPS) and Alternative Payment Model (APM) Incentive under the Physician Fee Schedule,…
BIO Comments on the National Quality Forum Health and Wellbeing 2015-2017 Report
December 23, 2016
BIO appreciates the opportunity to comment on the National Quality Forum (NQF) Health and Wellbeing 2015-2017 report.
BIO Submits Comments on FDA Draft Guidance: Coordinated Development of Antimicrobial Drugs and Antimicrobial Susceptibility Test Devices
December 23, 2016
Re: Docket No. FDA-2016-N-0001: The Biotechnology Innovation Organization (BIO) is pleased to submit the following comments on the Food and Drug Administration (FDA) Draft Guidance entitled, “Coordinated Development of Antimicrobial Drugs and…
BIO Urges the Senate to Pass the 21st Century Cures Act
December 7, 2016
On behalf of the Biotechnology Innovation Organization (BIO), I am writing to offer our strong support H.R. 34, the 21st Century Cures Act, and urge the Senate to pass this important legislation.
New York U.S. Congressional Delegation Sends Letter to PTO Head Michelle Lee
December 7, 2016
Ten members the U.S. House of Representatives from New York wrote to U.S. Patent and Trademark Office Director Michelle K. Lee to express concern with continued abuse of the inter partes review (IPR) system by financial speculators and other third…