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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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PFDD: BIO Comments on FDA Guidance Incorporating Clinical Outcome Assessments into Endpoints for Regulatory Decision Making
February 7, 2020
February 3, 2020 Dear Sir/Madam: The Biotechnology Innovation Organization (BIO) thanks the Food and Drug Administration (FDA or Agency) for the opportunity to submit comments regarding FDA’s public workshop on Patient-Focused Drug Development…
BIO's 2020 Special 301 Submission
February 6, 2020
Section 182 of the Trade Act of 1974, known as the “Special 301” provisions, requires the United States Trade Representative to identify countries that deny adequate and effective intellectual property protections or fair and equitable market access…
BIO Joins Letters Supporting EPA Nominee Michael Regan
February 4, 2020
The undersigned national agricultural organizations wish to extend our support for the nomination of Michael Regan to serve as Administrator of the Environmental Protection Agency.  Read the letter below:
BIO Comments on SEC Proposed Proxy Amendments
February 3, 2020
In comments to the Securities and Exchange Commission (SEC), BIO applauds the SEC for taking a proactive approach in amending the exemptions from the proxy rules for proxy voting. If adopted, the proposal will significantly improve proxy firm…
Office of New Drugs: BIO Comments on Promoting Effective Drug Development Programs: Opportunities and Priorities for the Food and Drug Administration's Office of New Drugs
January 10, 2020
January 7, 2020 Re: Docket No. FDA–2019-N-3453: Promoting Effective Drug Development Programs: Opportunities and Priorities for the Food and Drug Administration's Office of New Drugs Dear Sir/Madam: The Biotechnology Innovation Organization (BIO…
Clinical Outcomes and Endpoints: BIO Comments on Standard Core Sets: Clinical Outcome Assessments (COAs) and Endpoints Grant Program
January 10, 2020
January 4, 2020 Re: Docket No. FDA–2019-N-5157: 2019 Public Meeting on Center for Drug Evaluation and Research Standard Core Sets: Clinical Outcome Assessments and Endpoints Grant Program. Dear Sir/Madam: The Biotechnology Innovation Organization…
Select Committee on Climate Crisis: BIO Comments on Public Policies Needed to Help Biotech Address Climate Change
December 20, 2019
The Biotechnology Innovation Organization (BIO) is pleased to respond to the Select Committee's Request for Information (RFI) on how supportive public policy can help biotechnology reduce greenhouse gas emissions, enhance carbon sequestration,…
BIO Comments on FDA Guidance - IVD Device Studies Frequently Asked Questions
December 17, 2019
On December 16, 2019, the Biotechnology Innovation Organization (BIO) provided comments on the Food and Drug Administration’s (FDA’s) Notice to Public of Website Location of CDRH Fiscal Year 2020 Proposed Guidance Development; In Vitro…
BIO Comments on CMS National Coverage Decision Memo for Advanced Cancer Next Generation Sequencing
December 17, 2019
On November 27, 2019, the Biotechnology Innovation Organization (BIO) provided comments on the Centers for Medicare and Medicaid Services’ (CMS’) National Coverage Determination for Diagnostic Laboratory Tests using Next Generation Sequencing (NGS)…
More than 135 Emerging Biotech Leaders Urge Congress to Reject H.R. 3
December 5, 2019
In a letter addressed to House Speaker Nancy Pelosi (D-CA) and House Republican Leader Kevin McCarthy (R-CA), 138 emerging biotech leaders warn that H.R. 3, the Lower Drug Cost Now Act, will “shatter the dreams” of patients and families who stand to…