Загрузка...

Perspective: Communications with the Food and Drug Administration on the Development Pathway for a Cell-Based Therapy: Why, What, When, and How?

Effective interaction between key stakeholders and the U.S. Food and Drug Administration (FDA) is central to successfully navigating the regulatory process and advancing new therapies into clinical trials. This is especially true when developing cell-based therapies, which pose unique challenges to...

Полное описание

Сохранить в:

Библиографические подробности
Главные авторы:	Feigal, Ellen G., Tsokas, Katherine, Zhang, Jiwen, Cromer, Marc V., Whittlesey, Kevin J., Werner, Michael J.
Формат:	Artigo
Язык:	Inglês
Опубликовано:	AlphaMed Press 2012
Предметы:	Standards, Policies, Protocols, and Regulations for Cell-Based Therapies
Online-ссылка:	https://ncbi.nlm.nih.gov/pmc/articles/PMC3659665/ https://ncbi.nlm.nih.gov/pubmed/23197694 https://ncbi.nlm.nih.govhttp://dx.doi.org/10.5966/sctm.2012-0104
Метки:	Добавить метку Нет меток, Требуется 1-ая метка записи!

Perspective: Communications with the Food and Drug Administration on the Development Pathway for a Cell-Based Therapy: Why, What, When, and How?

Схожие документы