Abstract
The Food and Drug Administration has provided a mechanism to reduce time and resources expended on new pharmaceuticals, including radiopharmaceuticals, in order to identify the most promising agents for further development. The exploratory investigational new drug guidance describes early phase 1 exploratory approaches involving microdoses of potential drug candidates that are consistent with regulatory requirements while maintaining the safety needed for human subjects, allowing sponsors to move ahead more quickly with the development of new agents.
Original language | English |
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Pages (from-to) | 497-500 |
Number of pages | 4 |
Journal | Journal of Nuclear Medicine |
Volume | 56 |
Issue number | 4 |
DOIs | |
State | Published - Apr 1 2015 |
Keywords
- 21 CFRPart 212
- EIND
- Exploratory IND guidance
- First-in-human RP
- Microdosing