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Principles of Premarket Pathways for Combination Products

Principles of Premarket Pathways for Combination Products

January 2022

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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:

Guidance Document

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:

https://www.fda.gov/regulatory-information/search-fda-guidance-documents/principles-premarket-pathways-combination-products

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