Letters, Testimony & Comments

May 2, 2014
As with the FDA’s previous Guidance on this topic (2009 Guidance), BIO continues to support FDA‘s clarification of its views on the dissemination of medical journal articles and medical or scientific reference publications that contain...
April 29, 2014
Chairperson Mikulski, Ranking Member Shelby, Members of the Committee, thank you for the opportunity to provide you with written testimony on the extremely important topic of driving innovation through federal investments.  BIO is the world...
April 25, 2014
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Industry Organization (BIO) thanks the Food and Drug Administration (FDA) for the opportunity to submit comments on the Draft Guidance for Industry: New Chemical Entity Determinations for Certain...
April 22, 2014
The Biotechnology Industry Organization (BIO) thanks the Food and Drug Administration (FDA) for the opportunity to submit comments on the Request for Information (RFI) on “Standards for the Interoperable Exchange of Information for Tracing...
April 14, 2014
The member companies of BIO strongly support research that aims to improve human health through better drug development and recognize that responsibly sharing their clinical trial data can help to advance such research, while reinforcing public...
April 14, 2014
Dear Sir/Madam:   The Biotechnology Industry Organization (BIO) thanks the Food and Drug Administration (FDA) for the opportunity to submit comments on the FDA Draft Guidance on “Fulfilling Regulatory Requirements for...
April 2, 2014
The Honorable Patrick Leahy Chairman Committee on the Judiciary United States Senate Washington, D.C. 20510 The Honorable Chuck Grassley Ranking Member Committee on the Judiciary United States Senate...
March 28, 2014
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...
March 27, 2014
February 25, 2013     Marilyn Tavenner, B.S.N., M.H.A. Administrator Centers for Medicare & Medicaid Services Room 445–G, Hubert H. Humphrey Building 200 Independence Avenue, SW Washington, DC 20201  ...
March 27, 2014
VIA ELECTRONIC SUBMISSION   March 1, 2014     Patrick Conway, M.D. Deputy Administrator for Innovation and Quality Chief Medical Officer Centers for Medicare & Medicaid Services Center for Medicare and Medicaid...
March 25, 2014
Dear Chairman Wyden and Ranking Member Hatch:   As the Senate Finance Committee begins its work on tax extenders, we encourage you to extend the suite of critical advanced biofuels tax incentives – the Second Generation Biofuel...
March 10, 2014
BIO appreciates FDA’s efforts in convening its two day public workshop on January 6-7th entitled “Complex Issues in Developing Drug and Biological Products for Rare Diseases” as required by the Food and Drug Administration Safety...
March 7, 2014
  March 7, 2014   BY ELECTRONIC DELIVERY   Marilyn B. Tavenner Administrator Centers for Medicare & Medicaid Services U.S. Department of Health and Human Services Hubert H. Humphrey Building, Room 445-G 200...
March 7, 2014
On March 7, 2014, BIO submitted comments to the U.S. Office of Personnel Management (OPM) regarding OPM’s February 4, 2014 Multi-State Plan (MSP) Program Call Letter.  BIO’s comments address the critical nature of the Affordable...
March 4, 2014
March 4, 2014 Regulatory Analysis and Development PPD, APHIS Station 3A-03.8 4700 River Road Unit 118 Riverdale, MD 20737-1238   Re: U.S. Department of Agriculture Docket No. APHIS-2013-0047   Dear Sir or Madam:...
March 4, 2014
  Dear Sir/Madam: The Biotechnology Industry Organization (BIO) thanks the Food and Drug Administration (FDA) for the opportunity to submit comments on the “Request for Nominations: Drug Products that Present Demonstrable...
February 25, 2014
Stanford McCoy Assistant U.S. Trade Representative for Intellectual Property and Innovation Office of the U.S. Trade Representative Chair of the Special 301 Committee Office of the United States Trade Representative Washington, D.C....
February 25, 2014
BIO joined with the American Pharmacists Association (APhA), Association of State and Territorial Health Officials (ASTHO), Immunization Action Coalition (IAC), Merck, and the National Association of County and City Health Officials (NACCHO) to...