Manufacturing Site Change Supplements: Content and Submission: Guidance for Industry and Food and Drug Administration Staff

Issue Date: December 17, 2018
Issued by: Center for Biologics Evaluation and Research
Topic(s): Postmarket, Premarket Approval (PMA)
Status: Final

Manufacturing Site Change Supplements: Content and Submission: Guidance for Industry and Food and Drug Administration Staff

This guidance explains FDA’s current thinking regarding the following: (A) What constitutes a manufacturing site change and when you should submit a PMA supplement for a site change; (B) What documentation you should submit in a site change supplement; and (C) The general factors FDA intends to consider when determining whether to conduct an establishment inspection prior to approval of a site change supplement.

Download the Guidance Document