Full Info:

Resource Type:

Guidance Document

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:

https://www.fda.gov/media/90425/download