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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
John F. Crowley, President and CEO of the…
“Most favored nation is a deeply flawed proposal that would devastate our nation’s small- and mid-size biotech companies – the very companies that are the leading drivers of medical innovation in the United States and the cornerstone of America’s…
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CSBA Letter to Congressional Leadership on Most…
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CSBA Letter to Congressional Leadership on…
The Council of State Bioscience Associations (CSBA) is a coalition of independent state and territory-based non-profit trade associations, each of which advocates for public policies that support responsible development and delivery of innovative…
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BIO Comments to CMS on Oregon Proposed 1115 Waiver Application
April 1, 2022
The Biotechnology Innovation Organization (BIO) appreciates the opportunity to comment on the Oregon Health Authority’s (OHA) proposed Oregon Health Plan §1115 Demonstration Waiver Application (Waiver Application), which among other things, would be…
BIO Submits Comments in Response to FDA Guidance on Digital Health Technologies
March 21, 2022
On Monday, March 21st, BIO submitted comments in response to the recent FDA draft guidance, Digital Health Technologies for Remote Data Acquisition in Clinical Investigations. In the comments submitted, BIO expressed appreciation for the issuance of…
BIO Statement on House Science Committee Hearing on Bioenergy for Tomorrow
March 16, 2022
The Biotechnology Innovation Organization (BIO) is pleased to submit a statement for the record to the United States House of Representatives Committee on Science, Space, and Technology Subcommittee on Energy hearing entitled, Bioenergy…
BIO Statement to House Agriculture Committee on the 2022 Farm Bill and Climate Change
March 16, 2022
The Biotechnology Innovation Organization (BIO) is pleased to submit a statement for the record to the United States House of Representatives Committee on Agriculture hearing entitled, “A 2022 Review of the Farm Bill: The Role of USDA Programs…
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…