Home » Advocacy » Letters, Testimony & Comments

Letters, Testimony & Comments

Clinical Trials: BIO Submits Comments on FDA's Modernizing the Regulation of Clinical Trials
May 30, 2012
Dear Sir/Madam: BIO thanks the FDA for the opportunity to provide comments on Modernizing the Regulation of Clinical Trials and Approaches to Good Clinical Practice. BIO strongly supports efforts by FDA, industry, academia, and patient groups to...
BIO's Letter of Support for Passage of H.R. 5651, Food and Drug Administration Reform Act of 2012
May 30, 2012
Dear Speaker Boehner and Minority Leader Pelosi: On behalf of the Biotechnology Industry Organization (BIO), I am writing to express our support for H.R. 5651, the Food and Drug Administration Reform Act of 2012, which includes a reauthorization...
BIO Testimony to House Agriculture Subcommittee on Farm Bill Energy Programs
May 21, 2012
Testimony of the Honorable James C. Greenwood President and CEO, Biotechnology Industry Organization Subcommittee on Conservation, Energy, and Forestry Committee on Agriculture U.S. House of Representatives May 18, 2012 The...
BIO Comments on EPA SAB Draft Report: Biogenic Carbon Accounting
May 21, 2012
Comments of Biotechnology Industry Organization on EPA’s Science Advisory Board Deliberative Draft Report for Biogenic Carbon Accounting May 10, 2012  The Biotechnology Industry Organization (BIO) appreciates the opportunity to...
BIO Comments on Interagency Request for Information on Military Biofuels
May 21, 2012
September 30, 2011 Det 1 AFRL/PKMD ATTN: Laura J. Ortiz 2310 Eighth Street, Bldg 167 Wright-Patterson AFB OH 45433-7801 Via email at: laura.ortiz@wpafb.af.mil Re: Comments of the Biotechnology Industry Organization in response to RFI-...
DDI: BIO Comments on FDA's Draft Guidance for Industry Drug Interaction Studies
May 20, 2012
    Dear Sir/Madam:   The Biotechnology Industry Organization (BIO) thanks the Food and Drug Administration (FDA) for the opportunity to submit comments on the “Draft Guidance for Industry Drug Interaction Studies...
340B Program: BIO Comments on Health Resources and Services Administration (HRSA) Notice on the Enrollment and Recertification of Entities in the 340B Pricing Program
May 17, 2012
Re:      Proposed Project: Enrollment and Recertification of Entities in the 340B Drug Pricing Program (OMB No. 0915–0327)—Revision Dear Commander Pedley:         ...
BIO Comments on CMS Electronic Health Record Incentive Program
May 17, 2012
  The Biotechnology Industry Organization (BIO) appreciates this opportunity to comment on the Centers for Medicare and Medicaid Services’ (CMS) proposed rule specifying the Stage 2 criteria that eligible professionals (EPs), eligible...
CED: BIO Public Statement: Medicare Evidence Development & Coverage Advisory Committee Meeting, Evidentiary Characteristics for Coverage with Evidence Development (CED)
May 15, 2012
BIO Public Statement Medicare Evidence Development & Coverage Advisory Committee Meeting Evidentiary Characteristics for Coverage with Evidence Development (CED)   Thank you for the opportunity to present comments on behalf of the...
Biosimilars: BIO Comments on FDA's Biosimilars User Fee Cover Sheet
May 13, 2012
Dear Sir/Madam: The Biotechnology Industry Organization (BIO) thanks the Food and Drug Administration (FDA) for the opportunity to submit comments on the “Biosimilars User Fee Cover Sheet; Form 3792.”  BIO represents more than...
FDA Public Meeting: Approval Pathway for Biosimilar and Interchangeable Biological Products
May 11, 2012
Sara Radcliffe, executive vice president of health for BIO, presented at a Food and Drug Administration public hearing on the approval pathway for biosimilar and interchangeable biological products. The key issues she discussed included:...
Risk Evaluation: BIO Comments on ICH's Proposed Guideline on E2C(R2) Periodic Benefit-Risk Evaluation Report
May 10, 2012
  Dear Sir/Madam:   The Biotechnology Industry Organization (BIO) thanks the Food and Drug Administration (FDA) for the opportunity to submit comments on the International Conference on Harmonisation proposed guideline on E2C(R2)...
BIO's Suppport for the Reauthorization of the Prescription Drug User Fee Act (PDUFA V)
May 10, 2012
    Dear Chairman Upton and Ranking Member Waxman: On behalf of the Biotechnology Industry Organization (BIO), I am writing to express our support for the Food and Drug Administration (FDA) user fee program legislation, which...
Drug Safety: BIO Comments on FDA's Draft Guidance on Classifying Significant Postmarket Drug Safety Issues
May 7, 2012
  Dear Sir/Madam: The Biotechnology Industry Organization (BIO) thanks the Food and Drug Administration (FDA) for the opportunity to submit comments on the “Draft Guidance on Classifying Significant Postmarket Drug Safety Issues....
Drug Safety: BIO Comments on FDA's Communication to the Public
May 7, 2012
  Dear Sir/Madam:   The Biotechnology Industry Organization (BIO) thanks the Food and Drug Administration (FDA) for the opportunity to submit comments on the “Draft Guidance on Drug Safety Information—FDA’s...
BIO Endorsement Letter for the Senate Health, Education, Labor and Pensions Committee Markup of the Food and Drug Administration Safety and Innovation Act (FDASIA)
May 2, 2012
      On behalf of the Biotechnology Industry Organization (BIO), I am writing to express support for the Food and Drug Administration Safety and Innovation Act (FDASIA). I commend you for introducing this strong,...
International Patent Issues Highlighted at House Judiciary Committee Hearing: BIO Submits Biotech's Challenges
April 25, 2012
  The House Judiciary Committee conducted a hearing on World IP Day on "International Patent Issues: Promoting a Level Playing Field for American Industry Abroad."  BIO submitted written comments for the...
BIO's Testimony to the April 18, 2012 House Committee on Energy and Commerce, Subcommittee on Health Hearing on "FDA User Fees 2012: How Innovation Helps Patients and Jobs"
April 18, 2012
Chairman Upton and Pitts, Ranking Member Waxman and Pallone, Members of the Committee, it is my privilege to provide testimony before you today. My name is Sara Radcliffe and I am Executive Vice President for Health for the Biotechnology Industry...
Biosimilars: BIO Comments on Questions and Answers Regarding Implementation of BPCIA
April 16, 2012
The Biotechnology Industry Organization (BIO) thanks the Food and Drug Administration (FDA) for the opportunity to submit comments on the Draft Guidance for Industry on Biosimilars: Questions and Answers Regarding Implementation of the Biologics...
Biosimilars: BIO Comments on Quality Considerations
April 16, 2012
The Biotechnology Industry Organization (BIO) thanks the Food and Drug Administration (FDA) for the opportunity to submit comments on the “Draft Guidance for Industry on Quality Considerations in Demonstrating Biosimilarity to a Reference...