Matte Beauty – 679463 – 07/25/2024

Finished Pharmaceuticals/Unapproved New Drugs

Repare Skincare – 680247 – 07/25/2024

Finished Pharmaceuticals/Unapproved New Drugs

ISIS.GOLD – 679948 – 07/25/2024

Finished Pharmaceuticals/Unapproved New Drugs

Walmart, Inc. – 683095 – 07/25/2024

Finished Pharmaceuticals/Unapproved New Drugs

Amazon.com, Inc. – 679523 – 07/25/2024

Finished Pharmaceuticals/Unapproved New Drugs

CDER Emerging Drug Safety Technology Program (EDSTP)

The EDSTP is specifically focused on the use of artificial intelligence and other emerging technologies in pharmacovigilance and is part…

Emerging Drug Safety Technology Meetings (EDSTM)

CDER has established a meeting program called the Emerging Drug Safety Technology Meeting (EDSTM) program. Learn more.

FDA Compounding Documents and Actions

Find descriptions of some of the documents and actions, such as warning letters, recalls, Form 483 and inspection warrant, involved…

Surface Wipe Sampling of Hazardous Medicinal Products: A European Interlaboratory Comparison Study

This study aimed to conduct an interlaboratory comparison (ILC) program to evaluate the performance of European laboratories in detecting hazardous…