BIO Comments on Draft Guidance: Nonclinical Safety Evaluation of the Immunotoxic Potential of Drugs and Biologics
April 20, 2020
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(BIO) thanks the Food and Drug Administration (FDA or Agency) for the opportunity to submit comments on the “Draft Guidance: Nonclinical Safety Evaluation of the Immunotoxic Potential of Drugs and Biologics” (Draft Guidance or Guidance).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As noted in the introduction of the Draft Guidance, several guidance documents address, to variable extents, nonclinical immune system safety assessments.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existing guidances, as pointed out in the more detailed comments below, the language and organization of the proposed Draft Guidance lacks clarity and/or appears to conflict with existing guidance. In its current form we are concerned that the Draft Guidance will mislead some Sponsors, particularly those who do not have immunotoxicity expertise, and lead to either inadequate safety packages or unnecessary animal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.
Download Full Comments Below
BIO Comments on Nonclinical Safety Evaluation of the Immunotoxic Potential of Drugs and Biologics
BIO submits comments on the MDH’s proposed regulations regarding Drugs of Substantial Public Interest: Draft Methodology for Public Comment as required in statute by the Prescription Drug Price Transparency Act.
The Biotechnology Innovation Organization appreciates the opportunity to comment on the Center for Medicare and Medicaid Services’ Information Collection Request on the Part C and Part D Medicare Prescription Payment Plan Model Documents.
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(BIO) thanks the Food and Drug Administration (FDA or Agency) for the opportunity to submit comments on the “Draft Guidance: Nonclinical Safety Evaluation of the Immunotoxic Potential of Drugs and Biologics” (Draft Guidance or Guidance).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As noted in the introduction of the Draft Guidance, several guidance documents address, to variable extents, nonclinical immune system safety assessments.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existing guidances, as pointed out in the more detailed comments below, the language and organization of the proposed Draft Guidance lacks clarity and/or appears to conflict with existing guidance.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.