Letters, Testimony & Comments

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....
June 25, 2013
Re: Medicare Program; Hospital Inpatient Prospective Payment Systems for Acute Care Hospitals and the Long-Term Care Hospital Prospective Payment System and Proposed Fiscal Year 2014 Rates; Quality Reporting Requirements for Specific Providers;...
June 24, 2013
Re: Docket No. FDA–2013-D-0401: Draft Guidance for Industry: Safety Considerations for Container Labels and Carton Labeling Design to Minimize Medication Errors Dear Sir/Madam: The Biotechnology Industry Organization (BIO) thanks the...
June 19, 2013
A concerted effort through the TTIP to unleash the potential of biotechnology in the Transatlantic economy and beyond will go a long way to bringing innovative products to consumers, create jobs, and improve economic prospects on both sides of the...
June 19, 2013
BIO represents more than 1,100 biotechnology 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...
June 7, 2013
Countries across the globe are realizing the significant impact rare diseases have on their populations, and are responding by putting national policies in place to address these unmet medical needs.  BIO applauds the government of Brazil for...
June 3, 2013
Introduction The Biotechnology Industry Organization (BIO) appreciates the opportunity to respond to the Request for Comments issued by the U.S. Trade Representative on objectives to be pursued in the negotiation of a Transatlantic Trade and...