FDA发布PET药品监管问答最终指南
FDA Oversight of PET Drug Products Questions and Answers
FDA发布关于PET药品监管的问答式最终Level 1指南，内容涉及申请提交、审评、cGMP合规、检查、注册与列名及用户费用等环节。文件指出该指南反映FDA在当前阶段的看法，属建议性质，未设立可法律强制执行的责任。意见可通过档案编号FDA-2013-S-0610在线提交，或邮寄至FDA文件管理处。
GUIDANCE DOCUMENT
Final Level 1 Guidance
- Issued by:
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Guidance Issuing Office
Center for Drug Evaluation and Research
This guidance is intended to help producers of positron emission tomography (PET) drugs meet the requirements for FDA’s drug approval process. This guidance provides questions and answers that address nearly all aspects of the drug regulatory process, including application submission, review, compliance with current good manufacturing practices, inspections, registration and listing, and user fees.
FDA's guidance documents, including this guidance, do not establish legally enforceable responsibilities. Instead, guidances describe the Agency's current thinking on a topic and should be viewed only as recommendations, unless specific regulatory or statutory requirements are cited. The use of the word should in Agency guidances means that something is suggested or recommended, but not required.
Submit Comments
Submit comments on this guidance document electronically via docket ID: FDA-2013-S-0610 - Specific Electronic Submissions Intended For FDA's Dockets Management Staff (i.e., Citizen Petitions, Draft Proposed Guidance Documents, Variances, and other administrative record submissions)
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 comments should be identified with the title of the guidance.
来源：FDA Pharmaceutical Quality Documents · fda.gov