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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
Testimony of John F. Crowley President and CEO,…
Chairman Griffith, Chairman Guthrie, Ranking Member DeGette, Ranking Member Pallone, and distinguished members of the subcommittee, thank you for the opportunity to appear before you today on behalf of the Biotechnology Innovation Organization (BIO)…
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CSBA Letter to Congressional Leaders on PBM, PPRV…
Dear Congressional Leaders:On behalf of the Council of State Bioscience Associations (CSBA)—a national coalition of independent, state and territory-based organizations representing the full breadth of America’s biotechnology ecosystem—we write to…
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BIO's Comments on Advisory Committee on…
Re: Docket No. CDC-2025-0783; Advisory Committee on Immunization Practices (ACIP) MeetingDear Dr. Zadeh and Members of the ACIP:The Biotechnology Innovation Organization (BIO) appreciates the opportunity to provide comments to the Advisory Committee…
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BIO Comments on FDA Draft Guidance on Good Review Management Principles and Practices for New Drug Applications and Biologics License Applications
December 18, 2018
BIO submitted comments on the Food and Drug Administration’s (FDA) Draft Guidance, Good Review Management Principles and Practices for New Drug Applications and Biologics License Applications, Guidance for Industry and Review Staff. BIO appreciates…
Heading East: Biopharma International Expansion to China and Asia
December 17, 2018
This Special Report highlights the potential opportunities, entry approaches and local partner selection, and also include recommendations on market acceleration and internationalization.
BIO Comments on FDA Draft Guidance on Rare Diseases: Early Drug Development and the Role of Pre-IND Meetings
December 17, 2018
BIO submitted comments on the Food and Drug Administration’s (FDA) Draft Guidance, Rare Diseases: Early Drug Development and the Role of Pre-IND Meetings, which FDA says is intended to assist sponsors of drug and biological products for rare…
BIO Comments on FDA Guidance on Patient-Focused Drug Development: Methods to Identify What Is Important to Patients and Select, Develop, or Modify Fit-for-Purpose Clinical Outcome Assessments
December 14, 2018
BIO submitted comments to the Food and Drug Administration (FDA) following the public meeting, Patient-Focused Drug Development (PFDD) Guidance: Methods To Identify What Is Important to Patients and Select, Develop, or Modify Fit-for-Purpose…
BIO Comments on Patient-Focused Drug Development Guidance: Methods to Identify What Is Important to Patients and Select, Develop, or Modify Fit-for-Purpose Clinical Outcome Assessments
December 14, 2018
BIO submitted comments on the Food and Drug Administration’s (FDA) open docket, Patient-Focused Drug Development Guidance: Methods to Identify What Is Important to Patients and Select, Develop, or Modify Fit-for-Purpose Clinical Outcome Assessments…
BIO Comments on USTR Objectives for U.S. – Japan Trade Agreement
December 12, 2018
BIO supports the U.S. government entering negotiations with the Government of Japan as an opportunity to grow U.S. exports and create U.S. jobs. 
BIO Comments on ICH Q12 Draft Guideline
December 12, 2018
BIO submitted comments on the Food and Drug Administration (FDA) Draft Guideline, Q12 Technical and Regulatory Considerations for Pharmaceutical Product Lifecycle Management. BIO appreciates FDA’s commitment to harmonization of regulatory concepts…
BIO's Letters, Comments and Statements on 2018 Farm Bill
November 29, 2018
The following are letters, comments and statements the Biotechnology Innovation Organization wrote, organized or signed on to with regards to negogiations on the 2018 Farm Bill. 
BIO Comments on FDA Draft Guidance on Adaptive Designs for Clinical Trials of Drugs and Biologics
November 28, 2018
BIO submitted comments on the Food and Drug Administration’s (FDA) Draft Guidance, Adaptive Designs for Clinical Trials of Drugs and Biologics: Draft Guidance for Industry, which provides guidance to sponsors and applicants submitting…
BIO Comments on FDA Draft Guidance on Master Protocols: Efficient Clinical Trial Design Strategies to Expedite Development of Oncology Drugs and Biologics
November 28, 2018
BIO submitted comments on the Food and Drug Administration’s (FDA) Draft Guidance, Master Protocols: Efficient Clinical Trial Design Strategies to Expedite Development of Oncology Drugs and Biologics; Draft Guidance for Industry. BIO welcomes…