Author:
Margulis Andrea V.,Anthony Mary,Rivero-Ferrer Elena
Publisher
Springer Science and Business Media LLC
Reference21 articles.
1. Food and Drug Administration. Guidance for industry - establishing pregnancy exposure registries; 2002.
2. Food and Drug Administration. Procedures and responsibilities for developing postmarketing requirements and commitments - MAPP 6010.9; 2009.
3. • Gelperin K, Hammad H, Leishear K, Bird ST, Taylor L, Hampp C, et al. A systematic review of pregnancy exposure registries: examination of protocol-specified pregnancy outcomes, target sample size, and comparator selection. Pharmacoepidemiol Drug Saf. 2017;26(2):208–14. Systematic review of existing pregnancy exposure registries focusing on design features that are key to obtaining informative results for drug safety in pregnancy.
4. • Bird ST, Gelperin K, Taylor L, Sahin L, Hammad H, Andrade SE, et al. Enrollment and retention in 34 United States pregnancy registries contrasted with the manufacturer’s capture of spontaneous reports for exposed pregnancies. Drug Saf. 2018;41(1):87–94. Comparison of number of enrollees in pregnancy exposure registries with number of spontaneous reports of exposed pregnancies for a number of drugs.
5. Food and Drug Administration. Content and format of labeling for human prescription drug and biological products; requirements for pregnancy and lactation labeling (79 FR 72063); 2014.
Cited by
3 articles.
订阅此论文施引文献
订阅此论文施引文献,注册后可以免费订阅5篇论文的施引文献,订阅后可以查看论文全部施引文献