Abstract
As the Food and Drug Administration (FDA) tries to reduce the postapproval changes requiring preapproval, pharmaceutical manufacturers must learn the ropes of yet another guideline. This document summarizes the key issues, highlights critical points, and compares the FDA requirements to European Union (EU) requirements, as well as provides an overview table of the 1995 guidance on “Immediate Release Solid Oral Dosage Forms; Scale-Up and Postapproval Changes: Chemistry, Manufacturing and Controls; In Vitro Dissolution Testing; In Vivo Bioequivalence Documentation” [Docket No. 95 D-0349].
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References
1.
III/5729/95, Variations—Compilation of Documents.
2.
III/5783/93, Dossier Requirements for Type I Variations.