Novel Drug Approvals: Innovation in 2015Donald J. Dietz
A Review of CDER's Novel Drug Approvals for 2016 Posted on January 4,2017 by FDA Voice This past year was another successful year for the new drugs program in FDA's Center for Drug Evaluation and Research... J Jenkins - 《中国药学(英文版)》 被引量: 0发表: 2017年 A Thorough Analysis...
The agency approved 87% of the applications on the first cycle of review and met or exceeded the goal dates under the Prescription Drug User Fee Act for all but two of novel new drugs approved. FDA’s expedited pathways for drug approval again proved successful in 2015: Fourteen drugs wer...
Novel drug approvals for 2016. https://www.fda.gov/drugs/developmentapprovalprocess/druginnovation/ucm483775.htm. Accessed August 17, 2017. 3. Downing NS, Shah ND, Aminawung JA, et al. Postmarket safety events among novel therapeutics approved by the US Food and Drug Administration between 200...
S. Food and Drug Administration( FDA) in 2017 so as to provide references for drug regulators and new drug researchers. Methods: The information of the novel drugs approved by FDA in 2017 and over the years was collected form FDA official website and was analyzed. Results Conclusion: FDA ...
作者: 美国新药获批。 US FDA Novel Drug Approvals for 2024. 美国新药获批。🔗: 网页链接
Health-system pharmacists play a crucial role in monitoring the pharmaceutical pipeline to manage formularies, allocate resources, and optimize clinical programs for new therapies. This article aims to support pharmacists by providing updates on new and anticipated novel drug approvals. Summary Selected ...
[c]Tsinghua-Peking Center for Life Sciences, Beijing, China [d]Biostatistics and Bioinformatics, Duke University School of Medicine, Durham, NC, USA [e]Department of Pharmacy, Peking University People's Hospital, Beijing, China [f]Center for Drug Evaluation, National Medical Products Administration...
Apremilast: A Novel Drug for Treatment of Psoriasis and Psoriatic Arthritis. 来自 国家科技图书文献中心 喜欢 0 阅读量: 122 作者:SL Haber,S Hamilton,M Bank,SY Leong,E Pierce 摘要: To review the pharmacology, efficacy, and safety of apremilast and determine its role relative to other agents in...
The new functionality poses additional challenges, particularly in terms of stability (proteins and peptides), requirements for intracellular delivery (nucleic acids), and viability and expansion (living cells). To address these challenges, drug delivery strategies must evolve continuously [51]. For all...