CDRR Downloadables

CDRR Checklist

Drug Registration

Post-Approval Changes (PACs)

 

Guidance Documents


ASEAN Common Technical Dossier (ACTD)

Part I Part II Part III Part IV

 ASEAN Common Technical Requirements(ACTR)

 Analytical Validation Bioavailability & Bioequivalence Study Process Validation Stability Variation
For FDA use only AER No. 2012-0001 All Reports are Confidential "Saving Lives Through Vigilant Reporting" Suspected Adverse Reaction Form