Letters, Testimony & Comments

May 16, 2012
BIO Public Statement Medicare Evidence Development & Coverage Advisory Committee Meeting Evidentiary Characteristics for Coverage with Evidence Development (CED)   Thank you for the opportunity to present comments on behalf of the...
May 14, 2012
Dear Sir/Madam: The Biotechnology Industry Organization (BIO) thanks the Food and Drug Administration (FDA) for the opportunity to submit comments on the “Biosimilars User Fee Cover Sheet; Form 3792.”  BIO represents more than...
May 11, 2012
Sara Radcliffe, executive vice president of health for BIO, presented at a Food and Drug Administration public hearing on the approval pathway for biosimilar and interchangeable biological products. The key issues she discussed included:...
May 11, 2012
  Dear Sir/Madam:   The Biotechnology Industry Organization (BIO) thanks the Food and Drug Administration (FDA) for the opportunity to submit comments on the International Conference on Harmonisation proposed guideline on E2C(R2)...
May 10, 2012
    Dear Chairman Upton and Ranking Member Waxman: On behalf of the Biotechnology Industry Organization (BIO), I am writing to express our support for the Food and Drug Administration (FDA) user fee program legislation, which...
May 8, 2012
  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Organization (BIO) thanks the Food and Drug Administration (FDA) for the opportunity to submit comments on the “Draft Guidance on Drug Safety Information—FDA’s...
May 8, 2012
  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Organization (BIO) thanks the Food and Drug Administration (FDA) for the opportunity to submit comments on the “Draft Guidance on Classifying Significant Postmarket Drug Safety Issues....
May 2, 2012
      On behalf of the Biotechnology Industry Organization (BIO), I am writing to express support for the Food and Drug Administration Safety and Innovation Act (FDASIA). I commend you for introducing this strong,...
April 26, 2012
  The House Judiciary Committee conducted a hearing on World IP Day on "International Patent Issues: Promoting a Level Playing Field for American Industry Abroad."  BIO submitted written comments for the...
April 18, 2012
Chairman Upton and Pitts, Ranking Member Waxman and Pallone, Members of the Committee, it is my privilege to provide testimony before you today. My name is Sara Radcliffe and I am Executive Vice President for Health for the Biotechnology Industry...
April 16, 2012
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 Biosimilars: Questions and Answers Regarding Implementation of the Biologics...
April 16, 2012
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 Quality Considerations in Demonstrating Biosimilarity to a Reference...
April 16, 2012
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 Scientific Considerations in Demonstrating Biosimilarity to a Reference...
April 16, 2012
Re: Request for Comments Regarding Evidentiary Characteristics of Coverage with Evidence Development Dear Ms. Ellis:            The Biotechnology Industry Organization (BIO) appreciates this...
April 6, 2012
  Dear Senators Stabenow and Roberts and Representatives Lucas and Peterson: The U.S. is experiencing strong growth in the development and commercialization of biofuels, bioproducts, biopower, biogas, energy crops, renewable energy and...
April 2, 2012
Re:      CMS-2345-P (Proposed Rule, Medicaid Program; Covered Outpatient Drugs) Dear Ms. Tavenner: The Biotechnology Industry Organization (“BIO”) is pleased to submit the following comments to the Centers...
March 29, 2012
 Chairman Harkin, Ranking Member Enzi, Members of the Committee, it is my privilege to provide testimony before you today. My name is Sara Radcliffe and I am Executive Vice President for Health for the Biotechnology Industry Organization (BIO...
March 27, 2012
Dear Sir/Madam: The Biotechnology Industry Organization (BIO) thanks the Food and Drug Administration (FDA) for the opportunity to submit comments on the Agency’s Draft Guidance for Industry on Responding to Unsolicited requests for Off-...
March 27, 2012
Dear Sir/Madam: The Biotechnology Industry Organization (BIO) thanks the Food and Drug Administration (FDA or the Agency) for the opportunity to submit comments on this important topic.  The ability to exchange scientific information with...