Docket Number: FDA-2020-D-1824 Issued by: Guidance Issuing Office Center for Biologics Evaluation and Research Center for Drug Evaluation and Research The Food and Drug Administration (FDA […]
“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 […]
Speech by Robert M. Califf, M.D., MACC (Remarks as prepared for delivery) I’m delighted to be with you today. I want to thank Allison Bateman-House and […]
In 2022, generic drugs remained a significant public health priority for the FDA. Competition from generic drug makers helped make drugs more widely available and generally […]
Boxed Warning (sometimes referred to in lay terms as a “black-box warning”) Contains contraindications or warnings about serious adverse reactions2 that may lead to death or […]
For Immediate Release: February 20, 2024 Today, the U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency: Today, the […]
FDA’s labeling resources for human prescription drugs are primarily directed to industry staff who develop human prescription drug labeling: Contains a summary of the essential scientific […]
On this page Who is the audience for this webpage? FDA’s patient labeling specific resources on this webpage are primarily directed to industry staff who develop […]
Each year, CDER receives more than 300,000 submissions, amounting to millions of pieces of data. CDER reviews the data to bring lifesaving new drugs to market […]
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