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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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BIO Submits Comments on FDA Draft Guidance for the Development of Non-Opioid Analgesics for Acute Pain
April 11, 2022
On Monday, April 11th, BIO submitted comments in response to the FDA’s recent draft guidance on the Development of Non-Opioid Analgesics for Acute Pain. In the comments submitted, BIO reaffirmed its commitment to working with the Agency to achieve…
BIO Submits Statement to House Ag Hearing on 2022 Farm Bill and Renewable Energy
April 4, 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: Energy- Renewable Energy…
BIO Comments to EPA on GHG Modeling
April 1, 2022
The Biotechnology Innovation Organization (BIO) is pleased to submit these comments in response to the U.S. Environmental Protection Agency’s (EPA’s) February 28-March 1, 2022, workshop on biofuel greenhouse gas modeling.
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On Monday, March 21st, BIO submitted comments in response to the recent FDA draft guidance, Digital Health Technologies for Remote Data Acquisition in Clinical Investigations.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 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 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 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…