FDA 发布由申办者-研究者准备和提交 IND 的指南草案（FDA-2015-D-1484）
Investigational New Drug Applications Prepared and Submitted by Sponsor-Investigators
美国 FDA 发布指南草案 FDA-2015-D-1484，旨在帮助申办者-研究者向 CDER 和 CBER 准备并提交完整的 IND 申请。该草案不具约束力、暂不实施，同时讨论 IND 审评流程及申办者-研究者在临床研究中的一般职责。公众可随时按 21 CFR 10.115(g)(5) 提交意见。
GUIDANCE DOCUMENT
Draft
Not for implementation. Contains non-binding recommendations.
- Docket Number:
- FDA-2015-D-1484
- Issued by:
-
Guidance Issuing Office
Center for Drug Evaluation and Research
Center for Biologics Evaluation and Research
The purpose of this guidance is to assist sponsor-investigators in preparing and submitting complete investigational new drug applications (INDs) to the Center for Drug Evaluation and Research (CDER) and the Center for Biologics Evaluation and Research (CBER) at the Food and Drug Administration (FDA). Sponsor-investigators seeking to do clinical research often do not have the regulatory knowledge or the resources to hire experts to help them with the IND submission process. Although not an exhaustive step-by-step instruction manual, this guidance highlights certain elements of this process to facilitate a sponsor-investigator’s successful submission of an IND. This guidance also discusses the IND review process and general responsibilities of sponsor-investigators related to clinical investigations.
Submit Comments
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:
Dockets Management
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-2015-D-1484.
来源：FDA Pharmaceutical Quality Documents · fda.gov