의약품 관련 법령
Post-Complete Response Letter Meetings Between FDA and ANDA Applicants Under GDUFA
작성자 | 관리자 | ||
---|---|---|---|
작성일 | 2018-12-05 | 조회수 | 1,159 |
국가정보 | 북 아메리카>미국 | ||
출처 | FDA | ||
원문 | https://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM580175.pdf | ||
첨부파일 |
Post-Complete Response Letter Meetings Between FDA and ANDA Applicants Under GDUFA
- 이전글 Current Good Manufacturing Practice — Guidance for Human Drug Compounding Outsourcing Facilities Under Section 503B of the FD&C Act
- 다음글 Biomarker Qualification: Evidentiary Framework