Risk Basics for Medical Devices

Application of Risk Management Principles for Medical Devices

Is My Product A Medical Device

Conversations on Cancer – Perspectives on Cancer Care Decision-Making Among Older Adults

Medical Device Quality Management System Regulation Risk Management

Idea to IDE: A Medical Device in the Making

FDA Direct: Catching Up on Agency Reforms

Good Clinical Practice & Pharmacovigilance Compliance Symposium | D3S03-2 – Q&A Discussion Panel

FDA Direct: Removing Black Box Warnings for HRT (Part 1/2)

Cybersecurity Awareness for Connected Medical Devices

Public Meeting: Reauthorization of the Biosimilar User Fee Act

How is My Medical Device Classified?

Good Clinical Practice & Pharmacovigilance Compliance Symposium | D3S07 – Q&A Discussion Panel

FDA Direct: Removing Black Box Warnings for HRT (Part 2/2)

Medical Device Quality Management System Regulation Design and Development

Tobacco Products Scientific Advisory Committee Meeting, October 7, 2025

FDA Expert Panel on Testosterone Replacement Therapy for Men

Good Clinical Practice & Pharmacovigilance Compliance Symposium | D3S06 - (PV): Regulatory Updates

November 13, 2025: Pediatric Advisory Committee Meeting (PAC)

How is CDRH Structured?

Initiating the Removal of the “Black Box Warning” on Hormone Replacement Therapy