BIO provided detailed comments to the Office of Management and Budget (OMB) regarding the Initial Proposals For Updating OMB’s Race and Ethnicity Statistical Standards.
Letters, Testimony & Comments | May 1, 2023 | Drug Development Process
In these comments to FDA, BIO supports FDA’s efforts to improve future guidance related to Artificial Intelligence in Drug Manufacturing and outlines recommendations for FDA’s review and further consideration.
Letters, Testimony & Comments | September 20, 2017 | Human Health, Medical Counter-Measures, Policy & Regulatory, Medicaid
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 represents an industry that is devoted to…
FDA Approvals & Clinical Development Pipeline | Industry Analysis Reports, Policy & Regulatory
On behalf of its member companies and organizations, the Biotechnology Innovation Organization (“BIO”) extends its appreciation to NIST for considering these comments in response to the agency’s Draft Interagency Guidance Framework for Considering the Exercise of March-In Rights (the “draft…
Letters, Testimony & Comments | September 20, 2017 | BIO Announcements, Bioethics, Personalized Medicine
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 "Proposed Rule"). BIO members are eager to…
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 to submit these comments in response to the USDA’s…
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-Waxman Act.
BIO is pleased to submit these comments in response to the USDA Animal and Plant Health Inspection Service’s (APHIS’) request for public input on the proposed revisions to its biotechnology regulations in 7 CFR Part 340.