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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BIO Comments on FDA Draft Guidance on Human Gene Therapy for Retinal Disorder and Hemophilia
November 14, 2018
BIO submitted comments on the Food and Drug Administration’s (FDA) Draft Guidance on Human Gene Therapy for Retinal Disorder and Human Gene Therapy for Hemophilia. BIO says the guidance will assist stakeholders developing human gene therapy (GT)…
BIO Comments on Draft Guidance on Chemistry, Manufacturing, and Control (CMC) Information for Human Gene Therapy Investigational New Drug Applications (INDs)
November 14, 2018
BIO submitted comments on the Food and Drug Administration’s (FDA) Draft Guidance, Chemistry, Manufacturing, and Control (CMC) Information for Human Gene Therapy Investigational New Drug Applications (INDs). BIO says the comprehensive draft…
BIO Comments on Draft Guidance on Long-Term Follow-Up After Administration of Human Gene Therapy Products
November 14, 2018
BIO submitted comments on the Food and Drug Administration’s (FDA) Draft Guidance, Long-Term Follow-Up After Administration of Human Gene Therapy Products. BIO says the guidance reflects the FDA’s experience evaluating the safety of gene therapy…
BIO Comments on Proposed Changes to the NIH Guidelines for Research Involving Recombinant or Synthetic Nucleic Acid Molecules
October 16, 2018
BIO submitted comments to the National Institutes of Health (NIH) regarding the Proposed Changes to the NIH Guidelines for Research Involving Recombinant or Synthetic Nucleic Acid Molecules. BIO applauds the NIH’s efforts to support and advance…
BIO Comments on FDA Draft Guidance on Use of Expansion Cohorts in First-In-Human Clinical Trials
October 12, 2018
BIO submitted comments on the Food and Drug Administration’s (FDA) Draft Guidance, Expansion Cohorts: Use in First-In-Human Clinical Trials to Expedite Development of Oncology Drugs and Biologics. BIO welcomes FDA’s efforts to provide clear…
BIO Comments on FDA Draft Guidance on Opioid Use Disorder: Endpoints for Demonstrating Effectiveness of Drugs for Medication-Assisted Treatment
October 8, 2018
BIO submitted comments on the Food and Drug Administration’s (FDA) Draft Guidance, Opioid Use Disorder: Endpoints for Demonstrating Effectiveness of Drugs for Medication-Assisted Treatment. The draft guidance is an important step in clarifying the…
BIO Submits Comments Re: Hospital Outpatient Prospective Payment and Ambulatory Surgical Center Payment Systems (OPPS) and Quality Reporting Programs Proposed Rule
October 2, 2018
On September 24, BIO submitted final comments in response to the CY 2019 Outpatient Prospective Payment System Proposed Rule. This year’s OPPS rule included a Request for Information (RFI) around the potential development of a new innovation model…
BIO/Food Value Chain letter to Senate and House Appropriations Committee leadership in support of legislative language ensuring consistency under the National Bioengineered Food Disclosure Law
September 27, 2018
September 21, 2018The Honorable Richard Shelby                                        The Honorable Patrick LeahyChairman        …
BIO Comments on FDA Draft Guidance on Slowly Progressive, Low-Prevalence Rare Diseases with Substrate Deposition Resulting from Single Enzyme Defects: Providing Evidence of Effectiveness for Replacement or Corrective Therapies
September 25, 2018
BIO submitted comments on the Food and Drug Administration’s (FDA) Draft Guidance, Slowly Progressive, Low-Prevalence Rare Diseases with Substrate Deposition that Results from Single Enzyme Defects: Providing Evidence of Effectiveness for…
BIO Comments on Facilitating Competition and Innovation in the Biological Products Marketplace
September 21, 2018
BIO submitted comments for the Food and Drug Administration (FDA) public hearing on Facilitating Competition and Innovation in the Biological Products Marketplace, which took place on September 4, 2018. BIO remarked on the need to foster a robust,…