BIO Comments on Draft Guidance: Nonclinical Safety Evaluation of the Immunotoxic Potential of Drugs and Biologics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(BIO) thanks the Food and Drug Administration (FDA or Agency) for the opportunity to submit comments on the “Draft Guidance: Nonclinical Safety Evaluation of the Immunotoxic Potential of Drugs and Biologics” (Draft Guidance or Guidance).
As noted in the introduction of the Draft Guidance, several guidance documents address, to variable extents, nonclinical immune system safety assessments.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existing guidances, as pointed out in the more detailed comments below, the language and organization of the proposed Draft Guidance lacks clarity and/or appears to conflict with existing guidance. In its current form we are concerned that the Draft Guidance will mislead some Sponsors, particularly those who do not have immunotoxicity expertise, and lead to either inadequate safety packages or unnecessary animal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