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
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
CSBA Letter to Congressional Leadership on…
Learn more
BIO Comments to the USPTO’s MAY 10, 2024 Proposed…
BIO submitted these comments in response to the United States Patent and Trademark Office’s May 10, 2024, Notice of Proposed Rulemaking regarding Terminal Disclaimer Practice to Obviate Nonstatutory Double Patenting.
Learn more
All Letters, Testimony & Comments
  • Show All
Search
Results
BIO Comments to FDA on “Formal Meetings Between the Food and Drug Administration and Sponsors or Applicants of Prescription Drug User Fee Act Products”
December 18, 2023
In response to the request for information and comments, BIO submitted general comments and recommended edits (FDA-2017-D-6530)
BIO Comments to FDA on “Demonstrating Substantial Evidence of Effectiveness Based on One Adequate and Well-Controlled Clinical Investigation and Confirmatory Evidence”
December 18, 2023
In response to the request for information and comments, BIO submitted general comments and recommended edits (FDA-2023-D-2318)
BIO Comments to FDA on the draft guidance “Regulatory Consideration for Prescription Drug Use-Related Software.”
December 18, 2023
In response to the request for information and comments, BIO submitted general comments and recommended edits on the draft guidance (FDA-2023-D-2482)
CSBA Letter to Congressional Leadership Urging Support for the ORPHAN CURES ACT
December 7, 2023
This bipartisan and bicameral legislation is aimed at boosting rare disease drug development to ensure that patients have access to innovative therapies.
CSBA Letter in Support of ORPHAN Cures Act
December 7, 2023
The Council of State Bioscience Associations wrote House and Senate leaders to urge support of H.R. 5539 and S. 3131, the Optimizing Research Progress Hope and New Cures Act. 
Letter to Congressional Leaders in Support of 9003 Program
November 30, 2023
BIO Joins the Ag Energy Coalition, 10 allied organizations and 61 companies on a letter to House leadership urging support for the Biorefinery, Renewable Chemical and Biobased Product Manufacturing Assistance program (9003 program) in the Farm Bill…
BIO Comments to FDA on Alternative Tools: Assessing Drug Manufacturing Facilities Identified in Pending Applications
November 21, 2023
BIO provided general comments and recommended edits Re: FDA-2023-D-3031
BIO letter to FDA on Scientific Challenges and Opportunities to Advance the Development of Individualized Cellular and Gene Therapies
November 17, 2023
BIO submits comments in response to the agency’s request for information (FDA-2023-N-3742)
BIO letter to FDA on Labeling for Biosimilar and Interchangeable Biosimilar Products
November 17, 2023
BIO submits specific comments and recommended edits on the draft guidance 2016-D-0643
Letter to House and Senate Judiciary Committee Leadership on FTC-DOJ Regulation of Mergers
November 14, 2023
BIO joins 30 other national trade associations in speaking out against unprecedented and burdensome FTC-DOJ regulation of mergers