Open for Questions: Drug Master File Poster Sessions

A CDER Small Business and Industry Assistance (SBIA) Workshop

FDA | CDER | Small Business and Industry Assistance  CONFERENCES Drug Master File (DMF) and Drug Substance Workshop Poster Sessions Open for Questions March 3-4, 2021 Review FDA posters on DMFs and drug substances now. Submit your questions to DMFWorkshop2021@fda.hhs.gov. Listen to discussion on submitted questions during the conference.   Review Posters and Submit Questions to FDA Drug Substance Poster Topics Cocrystal APIs: Recommended Documentation Synthetic Therapeutic Polymers: Recommended Documentation for API sameness Synthetic Therapeutic Peptide APIs: Recommended Documentation for API Sameness & Related Impurities Regulatory Considerations for Synthetic and Semi-synthetic Oligosaccharide Complex APIs in Generic Products Quality Considerations for Continuous Manufacturing of APIs API Manufacturing Global Distribution and Facility Profile Analysis Evaluation of Metal Impurities in Drug Substances Establishing Impurity Acceptance Criteria as Part of Specifications for DMFs Based on Clinical Relevance Mutagenic Impurities from a Drug Substance Perspective: Highlights from the ICH M7 Question and Answer Draft Document DMF Poster Topics Timeline for the DMF Review process Completeness Assessments (CAs) Metrics on DMF Assessments Introduction to FDA Drug Master File Form 3938 ANDA Aligned Teams Review of Secondary Type II Drug Master Files The DMF Teleconference Process USP Pending Monograph Process and USP Compliance for Industry Communications with DMF Holders and Applicants throughout the DMF Lifecycle List of Relevant Quality Guidances & Common Deficiencies Observed during Drug Master File Review The Small Business and Industry Assistance (SBIA) program in the Center for Drug Evaluation and Research provides guidance, education and updates for regulated industry. Register for Upcoming Training Watch Learning Library Recordings on YouTube Subscribe to CDER SBIA Email Updates Follow on LinkedIn Follow on Twitter

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