cGMPs / QRM Process

Afnan to FDA: Simplify Post-Approval Changes, Spur Innovation

21 CFR 314.70, and the process by which FDA reviews changes to already approved applications, needs a risk-based update, now. Consultant Ali Afnan, formerly with FDA, makes his case.

If you are not automatically redirected, follow this link:
http://www.pharmaqbd.com/afnan_post_approval_changes/

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