Home
Search

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…
Learn more
CSBA Letter to Congressional Leadership on…
Learn more
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.
Learn more
All Letters, Testimony & Comments
  • Show All
Search
Results
BIO Submits Comments Re: ICER Proposed Value Assessment Framework Revisions
April 11, 2017
BIO submitted comments on the Institute for Clinical and Economic Review (ICER)'s call for proposed improvements to its Value Assessment Framework. While some of the proposed revisions have the potential to make progress toward aligning the…
BIO Comments on FDA's Revised Draft Guidance on Submission of Quality Metrics Data
March 27, 2017
The Biotechnology Innovation Organization (BIO) thanks the Food and Drug Administration (FDA) for the opportunity to submit comments on FDA’s Revised Draft Guidance for Industry Submission of Quality Metrics Data (Revised Draft Guidance).
Re: FDA-2016-N-4389: Genome Editing in New Plant Varieties Used for Foods; Request for Comment
March 16, 2017
March 9, 2017Division of Dockets Management (HFA-305) Food and Drug Administration 5630 Fishers Lane, Rm. 1061 Rockville, MD 20852.Re: FDA-2016-N-4389: Genome Editing in New Plant Varieties Used for Foods; Request for CommentTo whom it may concern…
Re: FDA-2008-D-0394: Regulation of Intentionally Altered Genomic DNA in Animals; Draft Guidance for Industry; Notice of Availability
March 16, 2017
March 13, 2017Division of Dockets Management (HFA-305)Food and Drug Administration5630 Fishers Lane, Rm. 1061Rockville, MD 20852Re: FDA-2008-D-0394: Regulation of Intentionally Altered Genomic DNA in Animals; Draft Guidance for Industry; Notice of…
BIO Submits Comments to FDA on Mixing, Diluting, or Repackaging Biological Products Outside the Scope of an Approved Biologics License Application
March 14, 2017
The Biotechnology Innovation Organization (BIO) thanks the Food and Drug Administration (FDA) for the opportunity to submit comments on FDA’s revised draft Guidance for Industry “Mixing, Diluting, or Repackaging Biological Products Outside the Scope…
BIO Comments on FDA Draft Guidance on Multiple Endpoints in Clinical Trials
March 14, 2017
The Biotechnology Innovation Organization (BIO) thanks the Food and Drug Administration (FDA) for the opportunity to submit comments on the Draft Guidance “Multiple Endpoints in Clinical Trials” (Draft Guidance).
BIO Testifies to House Agriculture Subcommittee on the Next Farm Bill
March 9, 2017
The Biotechnology Innovation Organization (BIO) is the world's largest trade association representing biotechnology companies, academic institutions, state biotechnology centers and related organizations across the United States and in more than 30…
Testimony of Kay Holcombe, Senior Vice President, Science Policy, Biotechnology Innovation Organization
March 2, 2017
What an honor it is to speak to you today on behalf of the Biotechnology Innovation Organization (BIO) about the Biosimilars User Fee Act reauthorization. This Committee planted the seed that has grown into multiple user fee programs that provide…
BIO Submits Comments to EMA on Strategies to Identify and Mitigate Risks for First-In-Human and Early Clinical Trials with Investigational Medicinal Products
February 28, 2017
The Biotechnology Innovation Organization (BIO) thanks the European Medicines Agency (EMA) for the opportunity to submit comments on the “Guideline on strategies to identify and mitigate risks for first-in-human and early clinical trials with…
BIO's Testimony in Opposition to Maryland's House Bill 666
February 27, 2017
Patrick Plues, BIO’s Vice President, State Government Affairs, testified before the Maryland House in opposition to House Bill 666, which would require biopharmaceutical manufacturers to disclose specific information on cost inputs for specific…