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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 Congressional Leadership on the…
One thing that we can all agree on is the need to give our children a fighting chance so they can lead long and productive lives. That is why it is critical to pass the bipartisan Give Kids a Chance Act and ensure the Pediatric Priority Review…
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John F. Crowley's One-Year Anniversary Letter to…
Dear Colleagues, This month marks my one-year anniversary as BIO's CEO. Like most of us in biotech, this post has been a labor of love. At no time in my 25-year career in this industry have I ever witnessed such awe-inspiring science. Today, we…
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BIO Comments on Office of Management and Budget …
Re: BIO Comments on Office of Management and Budget (OMB) Statistical Policy Directive No. 8 North American Industry Classification System (NAICS)-Request for Comments on Possible Revisions for 2027 (USBC–2024–0032)Dear Ms. Orvis,The Biotechnology…
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BIO Letter to USTR Ambassador Tai and Commerce Secretary Gino Raimondo on Indo-Pacific Economic Framework
March 11, 2022
The Biotechnology Innovation Organization (BIO) welcomes the White House announcement of the Indo-Pacific Strategy and supports efforts to reaffirm U.S. economic engagement with trading partner countries in the Indo-Pacific region and build an Indo…
BIO Comments on FDA Guidance: Considerations for the Use of Real-World Data and Real-World Evidence to Support Regulatory Decision-Making for Drug and Biological
March 8, 2022
On Tuesday, March 8th, BIO submitted comments in response to the recent Food and Drug Administration (FDA) guidance on the applicability of FDA's investigational new drug application (IND) regulations to various clinical study designs that utilize…
BIO Comments on FDA Guidance: Assessing Registries to Support Regulatory Decision-Making for Drug and Biological Products
February 28, 2022
On Monday, February 28th, BIO submitted comments in response to the recent Food and Drug Administration (FDA) guidance for sponsors on designing or using an existing registry to support regulatory decision-making about a drug's effectiveness or…
BIO Letter to OMB on Animal Biotech and the Need to Allow Draft Guidance
February 16, 2022
The Biotechnology Innovation Organization (BIO) writes this letter to urge the Biden Administration to take specific and immediate steps towards modernizing U.S. oversight of animals derived from biotechnology, especially those intended for…
BIO Comments to EPA on Proposed RFS Rules
February 4, 2022
The Biotechnology Innovation Organization (BIO) appreciates the opportunity to comment on the U.S. Environmental Protection Agency’s (EPA) proposed Renewable Fuel Standard (RFS) Program: RFS Annual Rules (86 Fed. Reg. 72436).
BIO Comments on Data Standards for Drug and Biological Product Submissions Containing Real-World Data
February 4, 2022
On Friday, February 4th, BIO submitted comments on the Food & Drug Administration’s (FDA) recent draft guidance regarding the data standards for product submissions containing Real-World Data (RWD). In the comments submitted, BIO thanked the…
BIO Submits Comments on USTR's 2022 Special 301 Review
January 31, 2022
The Biotechnology Innovation Organization (BIO) appreciates the opportunity to participate in the 2022 Special 301 Review: Identification of Countries under Section 182 of the Trade Act of 1974: Request for Public Comment and Announcement of Public…
BIO Comments on WHO Considerations on Regulatory Convergence of Cell and Gene Therapy Products
January 27, 2022
On Thursday, January 27th, BIO submitted comments in response to the World Health Organization’s (WHO) recently published white paper on the regulation of Cell and Gene Therapy Products (CGTPs). First and foremost, BIO acknowledged that the…
BIO Comments on Assessing Electronic Health Records and Medical Claims Data to Support Regulatory Decision-Making
January 24, 2022
On Monday, January 24th, BIO submitted comments in response to the Food & Drug Administration’s (FDA) draft guidance, Real-World Data: Assessing Electronic Health Records and Medical Claims Data to Support Regulatory Decision-Making for Drug and…
House Ways and Means Ranking Member Sends Letter to USTR on Need for USMCA Enforcement
January 12, 2022
It has been eighteen months since the entry into force of the United States-Mexico-Canada Agreement (“USMCA”), which modernized our trilateral trading relationship in ways that advance the interests of all Americans. The Agreement not only…