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 Quality System Information for Certain Premarket Application Reviews, Guidance for Industry

Origin/Publisher:

FDA

Document Type:
Guideline
Content:
This document discusses information required by the Quality System (QS) regulation (21 CFR part 820) that applicants should include in their premarket approval applications (PMA) and product development protocols (PDP).

Go back

GMP Conferences by Topics