FDA发布透皮和局部给药系统产品开发与质量考量指南草案
Transdermal and Topical Delivery Systems - Product Development and Quality Considerations
FDA发布《透皮和局部给药系统产品开发与质量考量》指南草案，就新药申请（NDA）和简化新药申请（ANDA）中应包含的药学开发和质量信息向申请人和生产商提出建议。草案涉及产品设计与药学开发、生产工艺与控制、成品控制，并讨论黏附失效和受热对给药影响等质量与产品性能相关议题。该文件为Level 1草案，不供实施，评论可随时提交，案卷号为FDA-2019-D-4447。
草案列出透皮和局部给药系统在开发、工艺与成品控制方面拟纳入申报的质量信息，并提及黏附失效和受热对给药的影响。
GUIDANCE DOCUMENT
Draft Level 1 Guidance
Not for implementation. Contains non-binding recommendations.
- Docket Number:
- FDA-2019-D-4447
- Issued by:
-
Guidance Issuing Office
Center for Drug Evaluation and Research
This guidance provides recommendations to applicants and manufacturers of transdermal and topical delivery systems (TDS) regarding the pharmaceutical development and quality information to include in new drug applications (NDAs) and abbreviated new drug applications (ANDAs). , Specifically, the guidance discusses FDA’s current thinking on product design and pharmaceutical development, manufacturing process and control, and finished product control. It also addresses special considerations for areas where quality is closely tied to product performance and potential safety issues, such as adhesion failure and the impact of applied heat on drug delivery.
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-2019-D-4447.
来源：FDA Pharmaceutical Quality Documents · fda.gov