의약품 관련 법령
ANDA Submissions — Amendments to Abbreviated New Drug Applications Under GDUFA
작성자 | 관리자 | ||
---|---|---|---|
작성일 | 2018-07-31 | 조회수 | 718 |
국가정보 | 북 아메리카>미국 | ||
출처 | |||
원문 | https://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM404440.pdf | ||
첨부파일 |
- 이전글 Oncology Therapeutic Radiopharmaceuticals: Nonclinical Studies and Labeling Recommendations Guidance for Industry
- 다음글 Use of Liquids and/or Soft Foods as Vehicles for Drug Administration: General Considerations for Selection and In Vitro Methods for Product Quality Assessments