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2021 CDER Small Business and Industry Assistance Webinars & Conferences

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OTC Monograph Reform: Deemed Final Orders

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Communications in a Global Pandemic

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Electronic Common Technical Document (eCTD)

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CDER NextGen Portal

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ANDA Efforts Related to COVID-19

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Plenary Session

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2021 REdI Conference Keynote Address by Janet Woodcock, MD

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Closing Remarks

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Complex Product Characterization/Analysis - Session 2C

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Complex Product Characterization/Analysis - Session 2B

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Complex Product Characterization/Analysis - Session 2A

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Identification of Medicinal Products: Path to Global Implementation

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FDA Regulatory Education for Industry (REdI) – Biologics Track

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FDA Regulatory Education for Industry (REdI) – Devices and Biologics Track

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FDA Regulatory Education for Industry (REdI) – Devices Track

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ANDA Labeling: Helpful Hints and Resources

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Product Specific Guidances Webinar – Opening Remarks

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FDA and Health Canada Regional ICH Consultation Part II

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FDA and Health Canada Regional ICH Consultation Part I

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Product Specific Guidances - Closing Remarks

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Controlled Correspondence Related to Pharmaceutical Quality

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Panel Discussion on Product-Specific Guidances

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Bioequivalence Regulations and Product-Specific Guidances

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Product-Specific Guidance Fundamentals from a Clinical Perspective

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Product-Specific Guidances for Complex Generic Drugs

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Non-Complex Drug Products and Product-Specific Guidances

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Overview of the FDA Product-Specific Guidance Program

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Panel Discussion

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Update on Shared System REMS for Generic Drugs

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Postmarketing Safety and Surveillance of Generic Drugs Update

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Panel Discussion

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Building a Better Sterility Assurance Application

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Integrated Manufacturing Assessment: Expectations

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Panel Discussion

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Assessment of Extractables/Leachables Data in ANDA Submissions

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Lab Science to Support Generic Complex Drug Product Assessment

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Fostering Innovation Through OPQ’s Emerging Technology Program

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Panel Discussion