Principles of Premarket Pathways for Combination Products Guidance for Industry and FDA Staff

Title:
Principles of Premarket Pathways for Combination Products Guidance for Industry and FDA Staff

https://www.gmp-compliance.org/files/guidemgr/2019-297-final guidance- Principles of Premarket Pathways for Combination Products (1-25-22) (1).pdf

Origin/Publisher:

FDA

Document Type:
Leitlinie
Content:
This guidance presents the current thinking of FDA on rinciples for premarket review of combination products.

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