Bulk Drug Guidance Should Include “Last True Solution” Control Point, PhRMA Urges
This article was originally published in The Pink Sheet Daily
Changes made prior to the last true solution pose a lower risk to a product’s physical and chemical properties and should have a lower regulatory burden, PhRMA says in recommendations to FDA on BACPAC II guidance. The group is pushing for specificity in the forthcoming guidance on post-approval changes for bulk active pharmaceuticals.
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