Dear Sir/Madam: The Biotechnology Innovation Organization (BIO) thanks the Food and Drug Administration (FDA or Agency) for the opportunity to submit comments on the “Draft Guidance: Nonclinical Safety Evaluation of the Immunotoxic Potential of Drugs and Biologics” (Draft Guidance or Guidance). General Comments: As noted in the introduction of the Draft Guidance, several guidance documents address, to variable extents, nonclinical immune system safety assessments. While the stated purpose of this Guidance is to supplement the recommendations provided in the existing guidances, as pointed out in the more detailed comments below, the language and organization of the proposed Draft Guidance lacks clarity and/or appears to conflict with existing guidance. In its current form we are concerned that the Draft Guidance will mislead some Sponsors, particularly those who do not have immunotoxicity expertise, and lead to either inadequate safety packages or unnecessary animal studies. Full the full comments, please click on the link below.

April 12, 2020   Re: Docket No. FDA–2019-D-5585: FDA Draft Guidance, Bridging for Drug-Device and Biologic-Device Combination Products.   Dear Sir/Madam: The Biotechnology Innovation Organization (BIO) thanks the Food and Drug Administration (FDA or Agency) for the opportunity to submit comments regarding the Draft Guidance, Bridging for Drug-Device and Biologic-Device Combination Products. BIO is the world's largest trade association representing biotechnology companies, academic institutions, state biotechnology centers and related organizations across the United States and in more than 30 other nations. BIO’s members develop medical products and technologies to treat patients afflicted with serious diseases, to delay the onset of these diseases, or to prevent them in the first place. BIO commends FDA for the development of the Draft Guidance on Bridging for Drug-Device and Biologic-Device Combination Products. Developers continue to face challenges with combination product development and review and guidance such as this provides important information for developers and helps alleviate challenges. BIO believes that the Draft Guidance presents a reasonable approach to bridging for combination products. The Draft Guidance appropriately provides a framework for sponsors to use in assessing what data are required for bridging and BIO believes that the approach taken in this Draft Guidance is more appropriate and flexible than outlining specific requirements for every bridging study. BIO has outlined in this letter suggestions for FDA’s consideration as the FDA is finalizing the Guidance.     BIO appreciates the opportunity to submit comments regarding FDA’s Draft Guidance, Bridging for Drug-Device and Biologic-Device Combination Products. We would be pleased to provide further input or clarification of our comments, as needed.