FDA held today ‘Drug Master File (DMF) Workshop: GDUFA III Enhancements and Structured Data Submissions’
The conference provided an update on the future state of DMF submissions and assessments including discussion of Knowledge-Aided Assessment and Structured Application (KASA), Structure-Data (SD) files and Global Substance Registration Systems (GSRS) database.
Dr. Naomi Kruhlak - Scientific Lead from FDA computational toxicology consultation services (CTCS) | Division of Applied Regulatory Science Office of Clinical Pharmacology discussed Improving Q(SAR) review with structure-Data files SD Files
Attached her presentation:
D1S15-Kruhlak.pdf (415.6 KB)
