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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 Submits Comments on FDA Guidance: Conducting…
On Friday, September 23rd, BIO submitted comments in response to a new draft guidance describing FDA’s perspective on its use of remote regulatory assessments (RRAs). In particular, the draft guidance responded to frequently asked questions on what…
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BIO Submits Comments on FDA Guidance: Clinical…
On Monday, September 26th, BIO submitted comments in response to the FDA’s draft guidance on clinical pharmacology considerations for development of oligonucleotide therapeutics, which provided recommendations on when certain PKPD assessments may be…
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Coalition Letter to Pres. Biden on High-Level…
BIO and 24 other organizations call on the Biden Administration to discuss supply chains and food security in future High-Level Economic Dialogue meetings.
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Coalition Letter to Pres. Biden on High-Level Economic Dialogue with Mexico
September 29, 2022
BIO and 24 other organizations call on the Biden Administration to discuss supply chains and food security in future High-Level Economic Dialogue meetings.
BIO Submits Comments on FDA Guidance: Clinical Pharmacology Considerations for the Development of Oligonucleotide Therapeutics
September 26, 2022
On Monday, September 26th, BIO submitted comments in response to the FDA’s draft guidance on clinical pharmacology considerations for development of oligonucleotide therapeutics, which provided recommendations on when certain PKPD assessments may be…
BIO Sends Letter to President Biden Strongly Opposing Expansion of the WTO TRIPS Waiver
September 26, 2022
We are writing to express our strong opposition to any form of expansion of the WTO TRIPS waiver to COVID-19 therapeutics or diagnostics. Support for an intellectual property (IP) waiver would send U.S.-developed innovative technologies and…
BIO Submits Comments on FDA Guidance: Conducting Remote Regulatory Assessments – Q&As
September 23, 2022
On Friday, September 23rd, BIO submitted comments in response to a new draft guidance describing FDA’s perspective on its use of remote regulatory assessments (RRAs). In particular, the draft guidance responded to frequently asked questions on what…
BIO Joins Letter to Congress Urging for Expeditious Confirmation of Doug McKalip as Chief Agricultural Negotiator at USTR
September 21, 2022
On behalf of the broad and diverse stakeholders in American Agriculture we represent, we urge you to work with your colleagues to expeditiously confirm Doug  McKalip as Chief Agricultural Negotiator at the Office of the U.S. Trade…
BIO Comments on FDA Guidance: Voluntary Consensus Standards Recognition Program for Regenerative Medicine Therapies
September 13, 2022
On Tuesday, September 13th, BIO submitted comments in response to the FDA’s recent draft guidance on voluntary consensus standards (VCS) for regenerative medicine therapies. In the comment letter, BIO expressed appreciation to FDA for issuing a…
BIO Comments on WHO White Paper: Regulation of Cell and Gene Therapy Products
September 9, 2022
Today, BIO submitted comments to the World Health Organization (WHO) regarding its revised, draft white paper on the regulation of Cell and Gene Therapy Products (CGTPs). As stated previously, BIO emphasized that this paper represents a major…
BIO Letter on Inflation Reduction Act Implementation, Climate & Biotechnology
September 8, 2022
As the federal government begins to implement IRA, BIO urges the administration to take additional steps to foster the development and deployment of pioneering technologies that will further reduce greenhouse gas emissions in manufacturing,…
BIO Comments on FDA Guidance for Risk Management Plans to Mitigate the Potential for Drug Shortages
August 31, 2022
Today, BIO submitted comments in response to the FDA’s recent draft guidance on the development, maintenance, and implementation of Risk Management Plans (RMPs). While the comment letter expressed broad support for the systematic approach for…
BIO Applauds Senator Tom Tillis for Introducing the Patent Eligibility Restoration Act
August 2, 2022
On behalf of the Biotechnology Innovation Organization, I want to thank you for introducing the Patent Eligibility Restoration Act. This important legislation will bring much-needed and overdue clarity to Section 101 of the Patent Act. The existing…