SBIA Learning Library: Most Viewed Presentations during First Quarter, 2021

CDER Small Business and Industry Assistance LEARNING LIBRARY .   SBIA Learning Library on YouTube Visit FDA's CDER Small Business and Industry Assistance (SBIA) YouTube Learning Library to view and share recordings of webinar and conference presentations from 2021, 2020, 2019, 2018, and 2017.    New content is posted on SBIA's LinkedIn page. These subject matter expert presentations are intended to educate and help industry navigate FDA policies and procedures.   Most Viewed Presentations in Previous Quarter 2021 Drug Master File (DMF) Submissions on New FDA Form 3938 Timeline for the Drug Master Review Process Risk Evaluation and Mitigation Strategies (REMS) Compliance Program More 2021 Recordings... 2020 Overview of the Guidance for Industry: Control of Nitrosamine Impurities in Human Drugs Establishment Registration and Drug Listing Compliance Program  Promoting Safe and Effective Prescription Drug Use in Geriatric Patients More 2020 Recordings... 2019 NDA and BLA Application Review Process Components of New Drug Application and Biologics License Application Electronic Common Technical Document (eCTD) and Study Data  More 2019 Recordings... 2018 Chemistry, Manufacturing, and Controls (CMC) for an IND Investigational New Drug (IND) Submission: Content/Format and First 30 Days Demystifying the Investigational New Drug (IND) Application for Drugs and Biologics More 2018 Recordings... 2017 Chemistry, Manufacturing Controls (CMC) in an Investigational New Drug (IND)  Overview of Non-clinical Assessment in Drug Development Introduction to Investigational New Drug (IND) Applications  More 2017 Recordings... The Small Business and Industry Assistance (SBIA) program in the Center for Drug Evaluation and Research  provides guidance, education and updates for regulated industry. Subscribe to CDER SBIA Email Updates Register for Upcoming Training View 2021 Recordings on YouTube Follow on LinkedIn Follow on Twitter

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