UNDERSTANDING OF SUPAC GUIDELINES (SCALE UP AND POST APPROVAL CHANGES):
This guidance provides recommendations to sponsors of new drug applications (NDA’s), abbreviated new drug applications (ANDA’s), and abbreviated antibiotic applications (AADA’s) who intend, during the post approval period, to change: SU: Scale-up during original dossier assessment. Note that this is not SU during development. Consider changes made after the Biobatch PAC: Post-PQ/post-approval, i.e. Variations. … Read more