FDA 发布未获批 PET 药物 IND 申请最终指南（FDA-2012-D-0081）
Investigational New Drug Applications for Positron Emission Tomography (PET) Drugs
FDA 发布最终指南 FDA-2012-D-0081，概述未获批正电子发射断层扫描（PET）药物的 IND 申请流程，并就如何提交 IND、研究性 PET 药物获取途径及申请收费许可的流程提出建议。该指南未涵盖扩大可及性申请与 IND 收费申请的全部考量，FDA 建议申办者查阅适用法规及官网建议，必要时咨询审评部门。
GUIDANCE DOCUMENT
Final
- Docket Number:
- FDA-2012-D-0081
- Issued by:
-
Guidance Issuing Office
Center for Drug Evaluation and Research
This guidance summarizes the investigational new drug application (IND) process for unapproved positron emission tomography (PET) drugs, makes recommendations on how to submit an IND, provides advice on investigational PET drug access options, and describes the process for requesting permission to charge for an investigational PET drug. This guidance does not describe all the considerations relevant to an Expanded Access submission or to an IND Request to Charge submission. For details about these processes, we encourage sponsors to review the applicable regulations and advice available on the FDA Web site, and consult the review division, if necessary.
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-2012-D-0081.
来源：FDA Pharmaceutical Quality Documents · fda.gov