The following guideline can be ordered through the address listed in the "Source/Publisher"-category. In cases in which you can order through the Internet we have established a hyperlink.

FDA Guidance for Industry: Principles of Premarket Pathways for Combination Products



This guidance presents the current thinking of FDA on principles for premarket review of combination products, including how to determine which type of premarket submission is appropriate.

Go back

GMP Conferences by Topics

Cookies help us in providing our services. By using our services, you agree that we use cookies. Further information