必应词典为您提供Pediatric-Research-Equity-Act的释义,网络释义: 儿科研究平安法;儿科研究平等法案;
pediatric equity research act of 2003“PERA”是什么意思 英文缩写PERA 英文全称pediatric equity research act of 2003 中文解释2003 年儿科股权研究法 缩写分类未分类 应用领域无领域 流行程度<50° 简要解释无 以上表格展示了“PERA”的主要定义,其中中文解释由机器翻译(标记“人工审核”除外)...
The Pediatric Research Equity Act Moves Into Adolescence Florence T. Bourgeois, MD, MPH1,2; Thomas J. Hwang, AB1,3 Author Affiliations JAMA. 2017;317(3):259-260. doi:10.1001/jama.2016.18131 Full Text Children continue to be underrepresented as participants in clinical trials, limiting the ...
The Best Pharmaceuticals for Children Act and Pediatric Research Equity ActHirschfeld, StevenDrug Research / Arzneimittel-Forschung (Editio Cantor Verlag fur Medizin und Naturwissenschaften)
Review of the Best Pharmaceuticals for Children Act and the Pediatric Research Equity Act: What can the obstetric community learn from the pediatric experience? Children have been called therapeutic orphans as they have been excluded from drug research and new drug development resulting in the lack ...
Earlier this month, the U.S. Food and Drug Administration (FDA) announced a public meeting entitled “Interested Parties Meeting: Implementation of the Best Pharmaceuticals for Children Act and Pediatric Research Equity Act” that is scheduled for May 15
In 2003, Congress passed the Pediatric Research Equity Act (PREA), reestablishing the mandate of the Pediatric Rule [2]. Table 1. US and EU Legislation Aff ecting Pediatric Research Regulatory Body Regulation Year Finalized Objective Incentive FDA The Pediatric Rule 1998 Mandates the conduct of...
This law amended the Pediatric Research Equity Act (PREA), Sec. 505B of the FD&C Act, to require molecularly targeted pediatric investigations of certain cancer drugs with new active ingredients. “[PREA] was enacted to compliment the incentive mechanisms provided by [the Best Pharmaceutica...
Database of pediatric medication labeling changes. Includes FDA data for drugs updated under the Pediatric Research Equity Act (PREA), Best Pharmaceuticals for Children Act (BPCA), and the Pediatric Rule. This repository aims to support informed decision-making in pediatric healthcare. ...
Ren Z, Zajicek A. Review of the Best Pharmaceuticals for Children Act and the Pediatric Research Equity Act: what can the obstetric community learn from the pediatric experience? Semin Perinatol. 2015;39:530–1.https://doi.org/10.1053/j.semperi.2015.08.006. ...