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Manufacturing Site Change Supplements: Content and Submission

Origin/Publisher:

FDA

Content:
This draft guidance explains FDA’s current thinking regarding the following: (A) What constitutes a manufacturing site change and when you should submit a PMA supplement for a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.

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