REdI 2024 | D2S08 – Compliance Approaches to Emerging Threats

The closing remarks to wrap up the Regulatory Education for Industry (REdI) Annual Conference 2024: Innovation in Medical Product Development. Timestamps 01:08 – Oversight Responsibilities 02:18 - Mission 02:33 – Compliance Tools and Activities 05:53 – Risk-Based Compliance Actions 06:39 – Safeguarding the Drug Supply Chain 12:09 – Remote Tools 17:24 – Ophthalmic Products 22:08 – Unapproved Drugs 24:45 – Warning Letters Issued 26:08 – Outreach and Communication 28:09 – Pharmaceutical Inspections and Compliance 31:12 – FDA Data Dashboard 33:34 – Unified Compliance 35:50 – Summary Speaker: Jill P. Furman, JD Director Office of Compliance (OC) Center for Drug Evaluation and Research (CDER) | FDA Learn more at: https://www.fda.gov/drugs/news-events-human-drugs/regulatory-education-industry-redi-annual-conference-2024-innovation-medical-product-development ----------------------- FDA CDER’s Small Business and Industry Assistance (SBIA) educates and provides assistance in understanding the regulatory aspects of human drug products & clinical research. Upcoming Training - https://www.fda.gov/cdersbia SBIA Listserv - https://public.govdelivery.com/accounts/USFDA/subscriber/new?topic_id=USFDA_352 SBIA 2024 Playlist - https://www.youtube.com/playlist?list=PLey4Qe-Uxcxaf1HvpvnKO8-n8u9QW412g SBIA LinkedIn - https://www.linkedin.com/showcase/cder-small-business-and-industry-assistance SBIA Training Resources - https://www.fda.gov/cdersbialearn Twitter - https://twitter.com/FDA_Drug_Info Email - CDERSBIA@fda.hhs.gov Phone - (301) 796-6707 I (866) 405-5367