Letters, Testimony & Comments

September 17, 2013
Pennsylvania House of Representatives Health Committee Hearing House Bill 746 September 11, 2013 Good Morning: My name is Fritz Bittenbender and I am the Senior Vice President of External Affairs at the Biotechnology Industry Organization....
September 16, 2013
    September 6, 2013   BY ELECTRONIC DELIVERY   Marilyn Tavenner Administrator Centers for Medicare & Medicaid Services Department of Health and Human Services Room 445-G Hubert H. Humphrey Building...
September 16, 2013
September 6, 2013   BY ELECTRONIC DELIVERY   Marilyn Tavenner Administrator Centers for Medicare & Medicaid Services Department of Health and Human Services Room 445-G Hubert H. Humphrey Building 200 Independence...
September 16, 2013
Dear Sir/Madam: The Biotechnology Industry Organization (BIO) thanks the Food and Drug Administration (FDA) for the opportunity to submit comments in response to its 2-day public meeting “Standardizing and Evaluating Risk Evaluation and...
September 13, 2013
Dear Sir/Madam: The Biotechnology Industry Organization (BIO) thanks the Food and Drug Administration (FDA) for the opportunity to submit comments on the proposed rule “Administrative Detention of Drugs Intended for Human or Animal Use....
September 13, 2013
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Organization (BIO) thanks the Food and Drug Administration (FDA) for the opportunity to submit comments on the “Draft Guidance for Industry on Circumstances That Constitute Delaying, Denying,...
September 13, 2013
GENERAL COMMENTS:   A. Comprehensive Approach to Pediatric Drug Development   BIO strongly supports a comprehensive approach to pediatric drug development crafted in the best interests of children and greatly appreciates recent...
August 26, 2013
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Industry Organization (BIO) thanks the Food and Drug Administration (FDA) for the opportunity to submit comments on the Draft Guidance for Industry on Expedited Programs for Serious Conditions—...
August 19, 2013
  BIO is concerned that the panel decision could have a number of unintended consequences, such as incentivizing defendants (or declaratory judgment plaintiffs) to employ dilatory tactics in the federal courts while re-arguing already-...
August 16, 2013
  March 15, 2013 Ms. Marilyn Tavenner, B.S.N., M.H.A. Acting Administrator Centers for Medicare & Medicaid Services Room 445–G, Hubert H. Humphrey Building 200 Independence Avenue, SW Washington, DC 20201 Re:...
August 5, 2013
Re: Docket No. FDA–2013–N–0271: Availability of Masked and De-identified Non-Summary Safety and Efficacy Data; Request for Comments   Dear Sir/Madam:   The Biotechnology Industry Organization (BIO) thanks the...
August 2, 2013
Joe V. Selby, M.D., M.P.H. Executive Director Patient-Centered Outcomes Research Institute 1701 Pennsylvania Ave. NW Suite 300 Washington, DC 20006   RE: Patient-Centered Outcomes Research Institute’s (PCORI’s)...
August 2, 2013
Louis Jacques, M.D. Director, Coverage and Analysis Group Centers for Medicare and Medicaid Services 7500 Security Boulevard Baltimore, MD 21244   RE: Proposed Decision Memorandum on National Coverage Analysis (NCA) for Beta-...
July 30, 2013
July 25, 2013 The Honorable Max Baucus, Chairman U.S. Senate Committee on Finance 219 Dirksen Senate Office Building Washington, D.C. 20510   The Honorable Orrin G. Hatch, Ranking Member U.S. Senate Committee on Finance...
July 29, 2013
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 on Contract Manufacturing Agreements: Quality Agreements...
July 25, 2013
Re: Docket No. FDA–2013–N–050: Standardizing and Evaluating Risk Evaluation and Mitigation Strategies; Notice of Public Meeting; Request for Comments   Dear Sir/Madam:   The Biotechnology Industry Organization (...
July 23, 2013
The Biotechnology Industry Organization (BIO) appreciates the opportunity to submit comments on the "Notification of Comment Period- 2013 Gapfill Payment Amounts Clinical Laboratory Fee Schedule (CLFS)" published by the Centers for...
July 18, 2013
July 18, 2013 The Honorable Max Baucus                                  ...
July 18, 2013
July 15, 2013 Air and Radiation Docket and Information Center Docket ID No. EPA-HQ-OAR-2012-0401 U.S. Environmental Protection Agency Mailcode: 6406J 1200 Pennsylvania Avenue, NW Washington, DC 20460 Via email at A-and-R-Docket@...