USC Mann Regulatory and Quality Sciences
YouTube channel for the Department of Regulatory and Quality Sciences at the University of Southern California. Visit here for informational videos about our programs for USC students as well as furthering education for the industry at large.
Approved and Emerging Hormone-Based Anti-Obesity Medications
Bridging the Gap in FDA Approval for Pediatric Neuromodulation Devices
Supply Chain of Radiopharmaceuticals, AI Enabled Medical Devices, Investigating Imported Drugs
Collection and Analysis of Adherence Information for Software as a Medical Device Clinical Trials
An Ethical Risk Management Approach for Medical Devices
Hemophilia Treatment Approved, Oyster Recall, Biosimilar Approvals
Digital Therapeutics and the Need for Regulation
Miniaturized Implantables & Bioelector Medicine
Dr. Makary Sworn In, FDA Educational Videos, Operation Stork Speed
Unapproved Fat Dissolving Injectables, CDER & CBER Updates, Gene Therapy Developments
Merck Safety Litigation, ‘Self-Affirm’ rule for Food Ingredient Safety, Dexcom Warning Letters
Evidence from Clinical Trials on High Risk Medical Devices in Children: A Scoping Review
Navigating the Regulatory Pathway for Medical Devices
Post Market Surveillance of Medical Devices
Spring 2025 Virtual Information Session
Beyond the 510(k): Moderate Risk Medical Devices, Intellectual Property, FDA's De Novo Pathway
Promoting Diversity through an Understanding of Barriers and Drivers for Inclusive Clinical Trials
Priorities for Medical Device Regulatory Approval: European Society of Cardiology Roundtable
Recommendations for a Predetermined Change Control Plan for AI-Enabled Device Software Functions
Glucose Monitor Technology, FDA approvals for Odactra, TNKase, and Xarelto
Granola Bar Recall, Fastrack and Breakthrough Designations, FDA Scientists Reinstated
FDA Probationary Firings, Vimseltinib Approval, Warning Letters
Alerts for smartphone compatible diabetes devices, Orphan drug designations, FDA compounding policy
Non-Opioid treatment for pain, Label expansion for Susvimo, AMG 513 on hold
Speed of access versus survival benefit of new cancer drugs
Oncology and Non-Oncology Drug Approvals and Withdrawals of USFDA and EMA
FDA focuses on reorganization, Welireg Priority Review, New Ozempic approval is a first
Ban on Red Dye 3, Nutrition Labeling Proposal, Recommendations for AI use
FDA Guidance for: Pulse Oximeters, Developers of AI Enabled Medical Devices, Sex Differences in CT
Mapping Strategies for Reaching Socioeconomically Disadvantaged Populations in Clinical Trials