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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 Comments on Global Benchmark for Efficient…
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BIO Comments on Guarding U.S. Medicare Against…
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Letter From BIO President & CEO John F. Crowley…
Dear Mr. Thune, Mr. Schumer, Mr. Johnson, and Mr. Jeffries:As President and CEO of the Biotechnology Innovation Organization (BIO), as a father and entrepreneur whose family is here today because of biotech innovation, and on behalf of the more than…
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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BIO Comments on FDA Draft Guidance on ANDAs for Certain Highly Purified Synthetic Peptide Drug Products Referring to Listed Drugs of rDNA Origin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BIO submitted comments on the Food and Drug Administration’s (FDA) Draft Guidance, ANDAs for Certain Highly Purified Synthetic Peptide Drug Products That Refer to Listed Drugs of rDNA Origin.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…
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.