FDA 发布 CBER 与 CDER 申报中生产设施标识问答定稿指南
Identification of Manufacturing Establishments in Applications Submitted to CBER and CDER Questions and Answers
FDA 发布 CBER 与 CDER 的定稿问答指南，说明原始 NDA、ANDA、原始 BLA 及其修订、补充和再提交中应如何填写生产设施信息。指南指出，在 Form FDA 356h 机构信息部分完整填写原料药与制剂设施信息，可减少信息请求（IR）、拒绝受理（RTF）和拒绝接收（RTR）。文件编号为 FDA-2017-D-6821。
该定稿问答指南说明申报文件中设施信息的填写位置与范围，并指出完整设施信息有助于减少信息请求及拒收情形。
GUIDANCE DOCUMENT
Final Level 2 Revised Guidance
- Docket Number:
- FDA-2017-D-6821
- Issued by:
-
Guidance Issuing Office
Center for Biologics Evaluation and Research
Center for Drug Evaluation and Research
This guidance is intended to clarify Agency expectations regarding facility information that should be included in original new drug application(s) (NDA); abbreviated new drug application(s) (ANDA); original biologics license application(s) (BLA); amendments; supplements; chemistry, manufacturing, and controls (CMC) supplements; and resubmissions to these submission types. Submission of Form FDA 356h fulfills the requirement for applicants to submit an application form (21 CFR 314.50(a) and 314.94(a)(1); 601.2(a)). Form FDA 356h serves as both a summary of administrative information, as well as a repository of complete information on the locations of all manufacturing, packaging, and control sites for both drug substance and drug product facilities associated with the application. This guidance addresses questions related to the inclusion and withdrawal of proposed commercial facilities and development facilities, the appropriate location within an application for facility information, and the type of facility information that should be included in applications. Applications that include appropriate and complete facility information in the establishment information section of Form FDA 356h will reduce the frequency of Information Request (IR), Refusal to File (RTF), and Refuse to Receive (RTR) actions and increase the efficiency of the application assessment process. This guidance describes the recommended placement of all facility information for both original and supplement applications.
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-2017-D-6821.
来源：FDA Pharmaceutical Quality Documents · fda.gov