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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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Governor's Biofuels Coalition Letter Urges EPA to Reject RFS Waivers
May 8, 2020
Undermining the RFS at a time when rural America is struggling economically, farmers are fighting to stay in business, and the biofuels industry has been impacted by furloughs and plant closures is unconscionable. We respectfully urge you to reject…
Senate Letter to Administration to Reject RFS Waivers
May 7, 2020
We urge you to direct the EPA to reject all calls to waive the RFS. The RFS is more important now than ever as farmers, the biofuel sector, and rural America struggle to remain operating amid the COVID-19 crisis.
BIO Comments on Draft Guidance: Nonclinical Safety Evaluation of the Immunotoxic Potential of Drugs and Biologics
April 20, 2020
Dear Sir/Madam: The Biotechnology Innovation Organization (BIO) thanks the Food and Drug Administration (FDA or Agency) for the opportunity to submit comments on the “Draft Guidance: Nonclinical Safety Evaluation of the Immunotoxic Potential of…
Combination Products: BIO Comments on FDA Draft Guidance, Bridging for Drug-Device and Biologic-Device Combination Products
April 17, 2020
April 12, 2020   Re: Docket No. FDA–2019-D-5585: FDA Draft Guidance, Bridging for Drug-Device and Biologic-Device Combination Products.   Dear Sir/Madam: The Biotechnology Innovation Organization (BIO) thanks the Food and Drug…
BIO Signs on to Letter Urging Federal Government to Protect Essential Workers
April 14, 2020
We support prioritizing the healthcare sector for COVID-19 testing supplies, and as testing becomes more available and abundant, the undersigned organizations urge the federal government to provide COVID-19 testing resources to U.S. employers that…
Letter Urging USDA to Include Biofuels in COVID-19 Economic Relief
April 9, 2020
Given the impact the economic downturn has had on all biofuel technologies, we request that USDA ensures all advanced and cellulosic biofuels are eligible to receive assistance from the additional funds provided to the Commodity Credit Corporation …
BIO Letter to White House on Need for Animal Biotech Reform in Wake of COVID-19
April 7, 2020
As part of the Administration’s comprehensive response to the unprecedented health and economic impacts from the COVID-19 pandemic, the Biotechnology Innovation Organization (BIO) respectfully requests that the U.S. government immediately reform its…
Joint Letter to USTR on Need to Address Mexico's Delays of Ag Biotech Approvals
March 31, 2020
The undersigned organizations greatly appreciate your support for agricultural biotechnology in trade negotiations and other bilateral and multilateral engagements. Biotechnology is delivering valuable tools that help farmers increase productivity,…
Clinical Development: BIO Comments on FDA Draft Guidance Demonstrating Substantial Evidence of Effectiveness for Human Drug and Biological Products
March 27, 2020
March 18, 2020 FDA Docket No: FDA-2019-D-4964: FDA Draft Guidance on Demonstrating Substantial Evidence of Effectiveness for Human Drug and Biological Products Dear Sir/Madam: BIO thanks FDA for developing this additional guidance on…
Pediatrics: BIO Comments on FDA Draft Guidance Pediatric Study Plans for Oncology Drugs: Questions and Answers
March 27, 2020
March 15, 2020 Re: Docket No. FDA–2019-D-4752: FDA Draft Guidance, Pediatric Study Plans for Oncology Drugs: Questions and Answers BIO appreciates FDA’s efforts to develop a document that outlines questions and answers pertaining to Pediatric…