Emergency Preparedness and Response

MCM Regulatory Science

FDA scientist adjusting equipment in lab at FDA headquarters at White Oak, MDThe goal of the Medical Countermeasures Initiative (MCMi) regulatory science program is to develop the tools, standards, and approaches to assess medical countermeasure safety, efficacy, quality, and performance and to help translate cutting-edge science and technology into innovative, safe, and effective medical countermeasures (MCMs).

FDA funds MCM regulatory science through intramural and extramural research grants, and forms scientific partnerships that help develop solutions to complex regulatory science challenges.

MCMi also works with FDA medical product centers to facilitate guidance and regulatory science to support the Animal Rule, which may be used to grant marketing approval of certain products when human challenge studies would not be ethical or feasible.

Related Information

Page Last Updated: 06/19/2018
Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players.
Language Assistance Available: Español | 繁體中文 | Tiếng Việt | 한국어 | Tagalog | Русский | العربية | Kreyòl Ayisyen | Français | Polski | Português | Italiano | Deutsch | 日本語 | فارسی | English