Letters, Testimony & Comments

March 26, 2013
Re: Docket No. FDA–2010-D-0643:  Draft Guidance for Industry on Electronic Source Data in Clinical Investigations; Availability Dear Sir/Madam: The Biotechnology Industry Organization (BIO) thanks the Food and Drug Administration (...
March 21, 2013
BIO commends the Government of Peru for its endeavor to create a pathway for the approval of biological and biotechnological products. Peru is a growing market for biotechnology products and with the implementation of the US-Peru TPA, it promises...
March 20, 2013
  Testimony of the Biotechnology Industry Organization (BIO) Hearing of the House Science, Technology & Energy Committee January 29, 2013 Regarding New Hampshire House Bill 1214: “AN ACT BANNING CORN-BASED ETHANOL AS AN...
March 20, 2013
  Testimony of the Biotechnology Industry Organization (BIO) Hearing of the Joint Committee on Environment and Natural Resources March 20, 2013 Regarding Maine Legislative Document 453 “AN ACT TO PROHIBIT THE SALE OF...
March 18, 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Organization (BIO) thanks the Food and Drug Administration (FDA) for the opportunity to submit comments on the “Draft Guidance for Industry on Enrichment Strategies for Clinical...
March 15, 2013
The Biotechnology Industry Organization (BIO) is the country’s largest biotechnology trade organization, representing over 1100 companies, academic institutions, and biotechnology centers in all 50 States and countries around the world...
March 14, 2013
  Dear Sir/Madam:   The Biotechnology Industry Organization (BIO) thanks the Food and Drug Administration (FDA or Agency) for the opportunity to submit comments on the Food and Drug Administration Drug Shortages Task Force and...
March 4, 2013
  The Biotechnology Industry Organization (BIO) thanks the Food and Drug Administration (FDA or Agency) for the opportunity to submit comments on the “Draft Revision of Guidance for Industry on Providing Regulatory Submissions in...
March 1, 2013
  BIO’s comments on the Centers for Medicare and Medicaid Services’ (CMS) draft 2014 Call Letter, submitted Friday, March 1.  BIO considers it especially important to focus attention on policies that impact access to...
March 1, 2013
  The Biotechnology Industry Organization (BIO) thanks the Food and Drug Administration (FDA) for the opportunity to submit written comments on the proposal to create an alternative approval pathway for certain drugs intended to address...
February 27, 2013
    Dear Sir/Madam:    The Biotechnology Industry Organization (BIO) thanks the Food and Drug Administration (FDA) for the opportunity to submit comments on the Guidance for Industry: Preclinical Assessment of...
February 22, 2013
BIO commends the government of Colombia for taking steps towards developing regulatory requirements for the registry of medicines of biological origin. Many elements of the third draft appear to have addressed BIO’s previous comments with...
February 21, 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: CMS–2334–P; Medicaid,...
February 19, 2013
  Testimony of the Biotechnology Industry Organization (BIO) Hearing of the House Energy & Utilities Subcommittee February 19, 2013 Regarding Florida House Bill 4001: “AN ACT RELATING TO THE FLORIDA RENEWABLE FUEL...
February 19, 2013
    The Biotechnology Industry Organization (BIO) thanks the Food and Drug Administration (FDA or Agency) for the opportunity to submit comments on the “Draft Guidance for Industry on Providing Submissions in Electronic Format...
February 8, 2013
Biotechnology companies provide unique benefits to the United States and the world. In the health care sector alone, the industry has developed and commercialized more than 300 biotechnology drugs and diagnostics and there are over 400 products in...
February 4, 2013
The Biotechnology Industry Organization (BIO) thanks the Food and Drug Administration (FDA) for the opportunity to provide comments on the proposal to create an alternative approval pathway for certain drugs intended to address unmet medical need...
February 1, 2013
BIO commends the INPI for their efforts to devise guidelines for examining biotechnology related inventions. Given the technological advances and the innovation that spurs it are the primary drivers of economic growth in the modern era, it is...