MEDIA CALL: FDA’s Final Rule on Laboratory Developed Tests – 04/29/2024

Idea to IDE: A Medical Device in the Making

The FSMA Final Rule on Requirements for Additional Traceability Records for Certain Foods

FDA Expert Panel on Testosterone Replacement Therapy for Men

Medical Device Quality Management System Regulation Risk Management

FDA Direct: FDA Awards Six National Priority Vouchers

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

Navigating the Quality Management System Regulation

FDA Direct: Catching Up on Agency Reforms

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

LACF and Acidified Foods Regulations and Requirements

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

Medical Device Quality Management System Regulation Design and Development

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

About FDA’s Biomarker Qualification Program

Tobacco Products Scientific Advisory Committee Meeting, October 7, 2025

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

GCP & Pharmacovigilance Compliance Symposium | D3S03-1 - (BE): Clinical Study Conduct

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

Good Clinical Practice & Pharmacovigilance Compliance Symposium | D3S04 - (PV): International...

Public Meeting: Reauthorization of the Biosimilar User Fee Act