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Current good manufacturing practice requirements for combination products

23 January 2017

Washington, DC

Medical Device and Pharmaceutical/Biotech Alert


On January 11, 2017, the U.S. Food and Drug Administration (FDA) issued a final guidance document entitled “Current Good Manufacturing Practice Requirements for Combination Products.”[1] This guidance describes and explains the agency’s January 22, 2013 final rule on current good manufacturing practice (CGMP) requirements for combination products (the Final Rule).[2]

Largely adhering to a January 2015 draft guidance that was put out for comment, the final guidance provides:

  • A discussion regarding the definition of a “combination product
  • An overview of the Final Rule
  • A description of the agency’s review of combination product CGMP issuesGeneral considerations for CGMP compliance and requirements for combination products. 

Read more for further details.

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