공지사항
[일반] [생산서비스운영 초청 세미나] 고려대학교 노인준 교수님
서울대학교 경영대학 생산서비스운영 전공에서 아래와 같이 해외 연사 초청 세미나를 개최하고자 합니다.
관심 있는 분들의 많은 참여를 부탁드립니다.
- 주제: Promoting Generics: Effects on Pharmaceutical Quality
- 일시: 5월 28일 (화) 09:30 - 11:00
- 장소: 58동 514호 (대면 진행)
- 발표자: 노인준 교수 (고려대학교 경영대학)
- 논문 초록: Generic drugs are a cornerstone of affordable healthcare. We examine the pharmaceutical quality effects of the Generic Drug User Fee Amendments (GDUFA), a hallmark legislation enacted by Congress in 2012 that armed the FDA with resources to improve the timeliness of generic drug application reviews. GDUFA succeeded in shortening the total application review time, which includes waiting time, from a median of 44 to 14 months. We find, however, that generic drugs approved after GDUFA have 28.6% higher recall rates. We show that this effect has been persistent since the second year of the law’s implementation, and that the increase in recall rates was driven by manufacturing-related deficiencies, specifically, contamination issues. We also investigate heterogeneity by recall severity and find that the increase in recalls after GDUFA is driven by severe (Class I and II) recalls. These findings inform previously unquantified quality reductions stemming from the policy promoting generic drugs.
- 담당 조교: 이수인 (soo971031@snu.ac.kr)
- 참석 가능 대상: 전공불문 학부생 및 대학원생 누구나 (사전 신청 불필요)
