- Docket Number:
- Issued by:
Guidance Issuing OfficeCenter for Drug Evaluation and Research
This document provides guidance concerning development of safety profiles to support use of new excipients as components of drug or biological products. It is intended for use by reviewers within both the Center for Drug Evaluation and Research (CDER) and the Center for Biologics Evaluation and Research (CBER) and by interested individuals in industry. It is also intended to foster and expedite the development of new excipients, communicate to pharmaceutical and excipient manufacturers current CDER and CBER recommendations on the nonclinical safety data that should be generated to support excipient development, and increase uniformity within CDER and CBER as to expectations for the nonclinical safety evaluation of excipients.
You can submit online or written comments on any guidance at any time (see 21 CFR 10.115(g)(5))
If unable to submit comments online, please mail written comments to:
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852
All written comments should be identified with this document's docket number: FDA-2002-D-0188.