Recent Use of Pediatric Extrapolation in Pediatric Drug Development in US.
Sign Up to like & getrecommendations! Published in 2023 at "Journal of biopharmaceutical statistics"
DOI: 10.1080/10543406.2023.2170407
Abstract: The regulatory standards of the United States Food and Drug Administration (FDA) require substantial evidence of effectiveness from adequate and well-controlled trials, for drugs developed in both adults and children. However, when scientifically justified, relying… read more here.
Keywords: pediatric drug; extrapolation; labeling changes; drug development ... See more keywords
Approvals, Submission, and Important Labeling Changes for US Marketed Pharmaceuticals
Sign Up to like & getrecommendations! Published in 2017 at "Hospital Pharmacy"
DOI: 10.1310/hpj5202-151
Abstract: This monthly feature will help readers keep current on new drug, new indications, dosage forms and safety-related changes in labeling or use. Efforts have been made to ensure the accuracy of this information; however, if… read more here.
Keywords: important labeling; submission important; changes marketed; labeling changes ... See more keywords