March 14, 2024

Drug Trials Snapshots: COLUMVI

HOW TO USE THIS SNAPSHOTThe information provided in Snapshots highlights who participated in the key clinical trials that supported the original FDA approval of this drug, […]
March 14, 2024

PQ/CMC Federal Register Notices

FDA has released several FRNs over the past few years covering the PQ/CMC project. As new sections of Module 3 eCTD (Electronic Common Technical Document) are […]
March 14, 2024

Q&A with FDA Podcast

“Q&A with FDA” provides engaging conversation and discussion about the latest regulatory topics. In this podcast series, FDA’s Division of Drug Information will answer some of […]
March 14, 2024

Patient Listening Session Summaries

FDA’s Patient Affairs is responsible for managing the Agency’s Patient Listening Session program. This page contains a list of all the Patient Listening Sessions that have been […]
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