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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
ohn’s One-Year Anniversary Letter to BIO…
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 forComments on Possible Revisions for 2027 (USBC–2024–0032)Dear Ms. Orvis,The Biotechnology…
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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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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…
BIO Comments on FDA Draft Guidance on Product Identifiers Under the Drug Supply Chain Security Act Q&A
November 19, 2018
BIO submitted comments on the Food and Drug Administration’s (FDA) Draft Guidance for Industry, Product Identifiers Under the Drug Supply Chain Security Act Questions and Answers. BIO member companies are committed to ensuring the U.S. drug supply…
BIO Comments on FDA Draft Guidance on Testing of Retroviral Vector-Based Human Gene Therapy Products
November 14, 2018
BIO submitted comments on the Food and Drug Administration’s (FDA) Draft Guidance, Testing of Retroviral Vector-Based Human Gene Therapy Products for Replication Competent Retrovirus During Product Manufacture and Patient Follow-Up. BIO agrees with…
BIO Comments on FDA Draft Guidance on Human Gene Therapy for Rare Diseases
November 14, 2018
BIO submitted comments on the Food and Drug Administration’s (FDA) Draft Guidance, Human Gene Therapy for Rare Diseases. BIO says the guidance will assist stakeholders developing human gene therapy (GT) products to treat rare diseases. BIO reminds…