Principles of Premarket Pathways for Combination Products
January 2022
Click to view Guidance Document
Principles of Premarket Pathways for Combination Products – Guidance for Industry and FDA Staff
January 2022 |
In this Technical Brief:
Health Risk(s):
- Combination Products
Product Type(s):
- Combination
Topic(s):
- Regulatory Issues
Region(s):
- United States
Full Info:
Resource Type:
Citation:
U.S. Department of Health and Human Services, Food and Drug Administration
Authors: Center for Biologics Evaluation and Research, Center for Devices and Radiological Health, Center for Drug Evaluation and Research Office of the Commissioner, Office of Clinical Policy and Programs, Office of Combination Products
Product type(s):
- MPTs
Topic(s):
- MPTs
- Development
- Regulatory
Region(s)
- United States
URL of resource: