D2S01-Skoda-v1.2-FINAL.pdf

1、Factors that Can Facilitate Assessment of Type II Drug Master Files(DMFs)Erin Skoda,Ph.D.Supervisory Pharmaceutical ScientistOffice of Product Quality Assessment III,OPQCDER|US FDASBIA Generic Drug Forum April 22-23,2026www.fda.gov3Objectives Identify items DMF Holders can include Identify items AND

2、A applicants can include Recognize missing information in DMFsHelp facilitate assessment of your type II DMF by learning to:www.fda.gov4Objectives Identify items DMF Holders can include Identify items ANDA applicants can include Recognize missing information in DMFsHelp facilitate assessment of your

3、 type II DMF by learning to:www.fda.gov5FDA Form 3938 What?Fillable form used for all DMF submissions Why?Expedites information processing Where?DMF Submission Resourceswww.fda.gov6Structure-Data(SD)File What?Chemical structure-data file in MOL connection table format Why?Unambiguous chemical struct

4、ure information to expedite assessmentFrom:Quick Guide to Creating a Structure-Data File for DMF submissionswww.fda.gov7Amendments What?Summary of changes How?Recommend Tabular Format Why?Clearly focuses on the updatesSectionCurrentChangeJustification*More detail can be included outside the summary

5、tablewww.fda.gov8Amendments:Changes What?Explain/justify changes Provide data as part of justification Discuss risk See:Consider Draft Guidance for Industry:Postapproval Changes to Drug Substanceswww.fda.gov9Objectives Identify items DMF Holders can include Identify items ANDA applicants can include

6、 Recognize missing information in DMFsHelp facilitate assessment of your type II DMF by learning to:www.fda.gov10Form 356h What?Form submitted with ANDA that includes referencing information.DMF numbers DMF drug substance facilities Why?Identifies related information for us to reviewwww.fda.gov11Sup