Letters, Testimony & Comments

May 8, 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Organization (BIO) thanks the Food and Drug Administration (FDA) for the opportunity to submit comments on the “Draft Guidance for Industry on Providing Postmarket Periodic Safety Reports in the...
May 7, 2013
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 Plan on “Structured Approach to Benefit-Risk Assessment in Drug Regulatory...
May 2, 2013
April 26, 2013 Docket No. FDA-2011-0899 Division of Dockets Management (HFA-305) Food and Drug Administration 5630 Fishers Lane, rm. 1061 Rockville, MD 20852 Re: FDA-2011-0899: Draft Environmental Assessment and Preliminary Finding of No...
April 23, 2013
April 22, 2013 Air and Radiation Docket Docket ID No. EPA-HQ-OAR-2013-0120 U.S. Environmental Protection Agency Mailcode: 6102T 1200 Pennsylvania Avenue NW Washington, DC  20460 via email at: a-and-r-docket@epa.gov Docket ID No. EPA-...
April 23, 2013
April 5, 2013 Air and Radiation Docket and Information Center Environmental Protection Agency Mailcode: 2822T 1200 Pennsylvania Avenue, NW Washington, DC  20460 via email at: a-and-r-docket@epa.gov Docket ID No. EPA-HQ-OAR-2012-0546:...
April 23, 2013
April 5, 2013 The Honorable Fred Upton    Chairman                             ...
April 19, 2013
The Biotechnology Industry Organization (BIO) appreciates the opportunity to comment on the “WHO Guidelines on the Quality, Safety, and Efficacy of Biological Medicinal Products Prepared by Recombinant DNA Technology.”  BIO...
April 12, 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Organization (BIO) thanks the Food and Drug Administration (FDA) for the opportunity to submit comments on the “Draft Guidance for Industry on Immunogenicity Assessment for Therapeutic Protein...
April 8, 2013
BIO supports the goals of the Affordable Care Act (ACA) in providing greater transparency regarding financial relationships with healthcare providers and we recognize the significant challenges that were presented in implementation of these ACA...
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Re: Docket No. FDA–2010-D-0643:  Draft Guidance for Industry on Electronic Source Data in Clinical Investigations; Availability Dear Sir/Madam: The Biotechnology Industry Organization (BIO) thanks the Food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...