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
Comments of the Biotechnology Innovation…
On behalf of its member organizations, Biotechnology Innovation Organization (“BIO”) respectfully submits this Comment in response to the United States Patent and Trademark Office’s (the “Patent Office” or “PTO”) February 13, 2024 Request for…
Learn more
BIO Comments to FWS on Use of GMOs on National…
BIO comments on a proposed rule to restrict planting of GE organisms on national wildlife refuge lands. 
Learn more
BIO Comments to the Minnesota Department of…
BIO submits comments on the MDH’s proposed regulations regarding Drugs of Substantial Public Interest: Draft Methodology for Public Comment as required in statute by the Prescription Drug Price Transparency Act.    
Learn more
All Letters, Testimony & Comments
  • Show All
Search
Results
Advance Notice of Proposed Rulemaking: International Pricing Index Model for Medicare Part B Drugs
December 31, 2018
BIO strongly opposes the potential proposal detailed in the Advance Notice of Proposed Rulemaking (ANPRM) on the International Pricing Index (IPI) and calls for withdrawal of the IPI model in its entirety.
BIO Sends Letter to President Trump on U.S.-China Trade & Biotech
December 18, 2018
The following letter was sent to the President of the United States in response to talks between the U.S. and China related to trade. 
BIO Comments on FDA Draft Guidance on Good Review Management Principles and Practices for New Drug Applications and Biologics License Applications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BIO submitted comments on the Food and Drug Administration’s (FDA) Draft Guidance, Good Review Management Principles and Practices for New Drug Applications and Biologics License Applications, Guidance for Industry and Review Staff.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BIO Comments on FDA Draft Guidance on Rare Diseases: Early Drug Development and the Role of Pre-IND Meetings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BIO submitted comments on the Food and Drug Administration’s (FDA) Draft Guidance, Rare Diseases: Early Drug Development and the Role of Pre-IND Meetings, which FDA says is intended to assist sponsors of drug and biological products for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 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 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 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.