Letters, Testimony & Comments

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Organization (BIO) thanks the Food and Drug Administration (FDA) for the opportunity to submit comments on the “Draft Guidance for Industry on Contract Manufacturing Agreements: Quality Agreements...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@...
July 18, 2013
July 1, 2013 Air and Radiation Docket and Information Center U.S. Environmental Protection Agency Mailcode: 2822T 1200 Pennsylvania Avenue, NW Washington, DC 20460 Via email at A-and-R-Docket@epamail.epa.gov Docket ID No. EPA-HQ-OAR-...
July 18, 2013
July 17, 2013 Docket No. APHIS-2013-0042 Docket No. APHIS-2013-0043 Regulatory Analysis and Development PPD, APHIS, Station 3A-03.8 4700 River Road Unit 118 Riverdale, MD 20737-1238 Re: Notice of Intent to Prepare an Environmental Impact...
July 18, 2013
Ambassador Michael Froman United States Trade Representative Office of the U.S. Trade Representative 600 17th Street N.W. Washington, D.C. 20508 Dear Ambassador Froman: The Biotechnology Industry Organization (BIO) writes to support the...
July 16, 2013
Re: Docket No. FDA–2013–N–020: Center for Drug Evaluation and Research Medical Policy Council; Request for Comments   Dear Sir/Madam:   The Biotechnology Industry Organization (BIO) thanks the Food and Drug...
July 10, 2013
Therapeutic biologics are an opportunity to address unmet patient needs, drive innovation, and assist China's transformation into a knowledge-intensive economy.  Benchmarking other countries, as well as China’s small molecule and...
July 10, 2013
Kenneth I. Moch President and Chief Executive Officer, Chimerix, Inc. On behalf of the Biotechnology Industry Organization Before the United States House of Representatives Committee on Financial Services, Subcommittee on Capital Markets and...
July 8, 2013
Biologics are complex medicines that are manufactured using living organisms.  Due to their size and complexity, biologics are distinctly different from traditional small-molecule drugs.  Any pathway for the approval of biosimilar...
July 8, 2013
In general, the Draft Guidance is well written and provides very useful clarification of the implementation of FDA’s regulations on expanded access to investigational drugs for treatment use under an investigational new drug application (IND...
July 3, 2013
Dear Dr. Conway: The Biotechnology Industry Organization (BIO) appreciates this opportunity to comment on Section 220.6 of the National Coverage Determination (NCD) Manual, which addresses coverage for Positron Emission Tomography (PET) scans....