Letters, Testimony & Comments

BIO submitted comments to the Food and Drug Administration (FDA) on Benefit-Risk Assessments in Drug Regulatory Decision-Making. The benefit-risk framework is an important advancement in FDA product regulation because it reflects and…

BIO submitted comments in response to the Health and Human Services (HHS/the Agency) Draft Strategic Plan for Fiscal Years 2018-2022. BIO strongly supports HHS’ mission to enhance the health and well-being of Americans, by providing for effective…

BIO submitted comments to the U.S. Pharmacopeial Convention (USP) Healthcare Quality and Safety Expert Committee (Expert Committee) in response to the second round of public comment on the USP Drug Classification System (USP DC), released September…

BIO President and CEO James C. Greenwood details deficiencies at the USPTO that are undermining longstanding and carefully-balanced procedures governing market entry and patent dispute resolution under the highly successful Hatch…

BIO submitted comments on the Food and Drug Administration’s (FDA) draft guidance, Chemistry, Manufacturing, and Controls Postapproval Manufacturing Changes for Specified Biological Products to Be Documented in Annual Reports. BIO appreciates the…

United States Department of Agriculture Jamie L. Whitten Building, Room 101-A 1400 Independence Ave SW Washington DC 20250 Re: Identifying Regulatory Reform Initiatives Dear Ms. Adcock: The Biotechnology Innovation Organization (BIO) is pleased…

BIO submitted comments in response to the Centers for Medicare and Medicaid Services' (CMS) proposed rule regarding the calendar year (CY) 2018 Physician Fee Schedule (PFS), other revisions to Part B, and Medicare Shared Savings Program (MSSP). BIO…

BIO submitted comments on the Centers for Medicare and Medicaid Services’ (CMS’s) Hospital Outpatient Prospective Payment and Ambulatory Surgical Center Payment Systems and Quality Reporting Programs Proposed Rule for calendar year (CY) 2018 (the …