의약품 관련 법령
Labeling for Human Pre-ion Drug and Biological Products Approved Under the Accelerated Approval Regulatory Pathway
작성자 | 관리자 | ||
---|---|---|---|
작성일 | 2019-01-22 | 조회수 | 1,411 |
국가정보 | 북 아메리카>미국 | ||
출처 | FDA | ||
원문 | https://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM390058.pdf | ||
첨부파일 |
Labeling for Human Prescription Drug and Biological Products Approved Under the Accelerated Approval Regulatory Pathway
- 이전글 A Risk-Based Approach to Monitoring of Clinical Investigations; Questions and Answers; Guidance for Industry
- 다음글 Providing Regulatory Submissions in Electronic Format - Certain Human Pharmaceutical Product Applications and Related Submissions Using the eCTD Specifications