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
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…
Learn more
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…
Learn more
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
All Letters, Testimony & Comments
  • Show All
Search
Results
Combination Products: BIO Comments on FDA Draft Guidance Human Factors Studies and Related Clinical Considerations in Combination Product Design and Development”
June 23, 2016
Re: Docket No. FDA-2015-D-4848: Human Factors Studies and Related Clinical Considerations in Combination Product Design and Development   Dear Sir/Madam:   The Biotechnology Innovation Organization (BIO) thanks the Food…
Biosimilars: BIO Comments on FDA Draft Guidance Labeling for Biosimilar Products
June 23, 2016
Re: Draft Guidance for Industry: Labeling for Biosimilar Products (Docket No. FDA-2016-D-0643 (April 4, 2016))   The Biotechnology Innovation Organization (“BIO”) welcomes the opportunity to submit comments on the Food and Drug…
CMC: BIO Submits Comments on FDA Draft Guidance Comparability Protocols for Human Drugs and Biologics: Chemistry, Manufacturing, and Controls Information
June 23, 2016
Re: Docket No. FDA-2016-D-0973: Comparability Protocols for Human Drugs and Biologics: Chemistry, Manufacturing, and Controls Information Dear Sir/Madam: The Biotechnology Innovation Organization (BIO) thanks the Food and Drug Administration (FDA)…
Office of the National Coordinator for Health Information Technology; Medicare Access and CHIP Reauthorization Act of 2015; Request for Information (RFI) Regarding Assessing Interoperability for MACRA
June 3, 2016
The Biotechnology Innovation Organization (BIO) is pleased to submit the following comments in response to the Request for Information (RFI) Regarding Assessing Interoperability for MACRA (the “RFI”).1 BIO is the world's largest trade association…
BIO Letter to Senate Appropriations Leadership on Efforts to Label Foods Produced Through Biotechnology Such As the Genetically Engineered Salmon
May 19, 2016
The Biotechnology Innovation Organization (BIO) urges you and all members of the Senate Appropriations Committee to support a national bioengineered food labeling legislative solution, which Senators Pat Roberts (R-KS) and Debbie Stabenow (D-MI)…
BIO Submits Comments to FDA's Draft EA and Preliminary FONSI Regarding the Proposed Field Trial of the OX513A Strain of Aedes aegypti (Ae. aegypti)
May 18, 2016
The Biotechnology Innovation Organization (BIO) appreciates this opportunity to provide comments to the U.S. Food and Drug Administration (FDA) on the draft environmental assessment (EA)1 and preliminary finding of no significant impact (FONSI)…
BIO Comments Re: Comments on Sharing Clinical Trial Data: A Proposal From the International Committee of Medical Journal Editors
May 17, 2016
Dear Dr. Taichman: The Biotechnology Innovation Organization (BIO) is pleased to offer the following comments on Sharing Clinical Trial Data: A proposal from the International Committee of Medical Journal Editors (“ICMJE”) (“the Proposal”). 1 BIO…
BIO Comments on FDA Natural Food Labeling
May 11, 2016
The Biotechnology Innovation Organization (BIO) is pleased to submit these comments to FDA in response to FDA’s request for information on the use of the term “natural” on food labeling (docket no. FDA-2014-N-1207). BIO is the world's largest…
BIO Submits Comments Re: Medicare Program; Part B Drug Payment Model [CMS-1670-P]
May 9, 2016
The Biotechnology Innovation Organization appreciates this opportunity to submit comments on the Centers for Medicare and Medicaid Services’ proposed rule entitled Medicare Program; Part B Drug Payment Model...
Follow-Up on BIO’s Comments in Response to the ICER Value Framework
May 4, 2016
The Biotechnology Innovation Organization (BIO) would like to take the opportunity to follow-up and expand on the feedback we originally submitted to the Institute for Clinical and Economic Review (ICER) in October 2015 on the ICER Value Framework …