
Guidance for Industry and FDA Staff: Current Good Manufacturing Practice Requirements for Combination Products
January 2017
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Guidance for Industry and FDA Staff: Current Good Manufacturing Practice Requirements for Combination Products
January 2017 |
- Combination Products
- Manufacturing
- MPTs
- Regulatory Issues
- United States
Full Info:
Resource Type:
Citation:
U.S. Department of Health and Human Services, Food and Drug Administration, Office of Combination Products (OCP) in the Office of the Commissioner, Center for Biologics Evaluation and Research (CBER), Center for Drug Evaluation and Research (CDER), Center for Devices and Radiological Health (CDRH), Office of Regulatory Affairs (ORA) (2017)
Authors:
U.S. Department of Health and Human Services, Food and Drug Administration, Office of Combination Products (OCP) in the Office of the Commissioner, Center for Biologics Evaluation and Research (CBER), Center for Drug Evaluation and Research (CDER), Center for Devices and Radiological Health (CDRH), Office of Regulatory Affairs (ORA)
Health Risks(s):
- HIV
- STI / STD
- Unintended Pregnancy
Product type(s):
- MPTs
Topic(s):
- MPTs
- Development
- Regulatory
Region(s)
- United States
URL of resource: