FDA 发布口腔崩解片行业指南定稿（FDA-2007-D-0365）
Orally Disintegrating Tablets
FDA 发布口腔崩解片（ODT）行业指南定稿，指出 ODT 与咀嚼片、需用液体整片吞服的片剂属于不同剂型。文件为希望将拟议产品指定为 ODT 的申请人提供建议，文件编号为 FDA-2007-D-0365。该指南由 CDER 发布，2008 年 12 月定稿，公众可随时按 21 CFR 10.115(g)(5) 提交意见。
GUIDANCE DOCUMENT
Orally Disintegrating Tablets Guidance for Industry December 2008
Final
- Docket Number:
- FDA-2007-D-0365
- Issued by:
-
Guidance Issuing Office
Center for Drug Evaluation and Research
This guidance provides pharmaceutical manufacturers of new and generic drug products with an Agency perspective on the definition of an orally disintegrating tablet (ODT)—which is a different dosage form than, for example, a chewable tablet or a tablet that should be swallowed whole with liquid—and also provides recommendations to applicants who would like to designate proposed products as ODTs.
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-2007-D-0365.
来源：FDA Pharmaceutical Quality Documents · fda.gov