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Biomilars: BIO Comments on FDA Draft Guidance Statistical Approaches to Evaluate Analytical Similarity

Re: Docket No. FDA-2017-D-5525: Statistical Approaches to Evaluate Analytical Similarity ...

BIO Submits Comments Re: CMS Innovation Center New Direction Request for Information

BIO submitted comments in response to the CMS Innovation Center New Direction Request for Information (RFI). BIO represents an industry that is devoted to discovering new treatments and ensuring patient access to them. Accordingly, we have closely monitored the Innovation Center’s development and delivery of demonstration models and their potential impact on patient access to treatment and innovation. BIO applauds CMS for engaging in the collection of broad stakeholder feedback through this RFI, and not only for seeking input on the model focus areas, but also on the overarching principles that guide the Innovation Center’s activities (guiding principles). We support the Center for Medicare and Medicaid Innovation’s (CMMI’s) broader goal to improve quality of care and reduce overall healthcare expenditures, and believe appropriate access to, and utilization of, medicines can contribute to both goals. Innovative therapies have the potential to improve patient health outcomes and reduce healthcare spending in the short- and long-term. Thus, a prominent theme of our comments on this RFI center on the ideal that all demonstrations should not only maintain, but improve access to necessary therapies.

BIO Comments to FDA on “Agricultural Biotechnology Education and Outreach Initiative; Public Meetings; Request for Comments” (FDA-2017-N-5991; November 17, 2017)

Re: FDA-2017-N-5991: “Agricultural Biotechnology Education and Outreach Initiative; Public Meetings; Request for Comments” To whom it may concern: The Biotechnology Innovation Organization (BIO) appreciates this opportunity to provide comments to the Food and Drug Administration (FDA) on its proposed Agricultural Biotechnology Education and Outreach Initiative (FDA-2017-N-5991). BIO is the world's largest biotechnology trade association, representing small and large companies, academic institutions, state biotechnology centers and related organizations across the United States and in more than 30 other nations. BIO members are involved in the research and development of agricultural, healthcare, industrial and environmental biotechnology products. BIO represents its members in a number of matters related to the uses of biology-based technologies in agriculture, animal health and human health.

Benefit-Risk: BIO Comments on Benefit-Risk Assessments in Drug Regulatory Decision-Making

Dear Sir/Madam: ...

BIO Submits Comments Re: HHS Draft Strategic Plan FY 2018-2022

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 health and human services and by fostering sound, sustained advances in the science of underlying medicine, public health, and social services; and the associated strategic planning process.

BIO Submits Comments Re: USP Drug Classification System, Second Round of Public Comments

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 25, 2017. In response to the USP DC, BIO offers comments consistent with our comprehensive comments on the draft Version 7.0 Medicare Model Guidelines (MMG) and comments on last year’s draft USP DC, both of which are included as appendices for the Expert Committee’s reference. Our comments, as follows, also correspond to the call for additional feedback on how to make the USP DC more user friendly as expressed on the open-mic web meeting.

CMC: BIO Comments on FDA Draft Guidance CMC Postapproval Manufacturing Changes for Specified Biological Products to be Documented in Annual Reports

 

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BIO's Letter to the Senate Committee on Judiciary Regarding Deficiencies at the USPTO

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 Comments to USDA’s Office of Budget and Program Analysis on Identifying Regulatory Reform Initiatives, September 15, 2017

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 request for information on “Identifying Regulatory Reform Initiatives,” published in the Federal Register on July 17, 2017.1 Thank you for the opportunity to provide input as the U.S. Department of Agriculture (USDA or the Agency) considers opportunities to improve customer service and remove unintended barriers to participation in its programs in ways that least interfere with its customers and allow USDA to accomplish its mission.

BIO Submits Comments Re: Medicare CY 2018 Revisions to Payment Policies Under the Physician Fee Schedule (PFS) and Other Revisions to Part B

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 discovering new treatments and ensuring patient access to them. Accordingly, we closely monitor changes to Medicare’s reimbursement rates and payment policies for their potential impact on innovation and patient access to drugs and biological. In this letter, BIO responds to CMS’s proposals in the order in which the Agency addresses each issue in the Proposed Rule, for ease of reference. However, there are several issues of particular importance to our members given the goal of ensuring patient access to necessary vaccines, treatments, and therapies.