Medical Gases — Current Good Manufacturing Practice

FDA is announcing an Early Alert for Abiomed’s Automated Impella Controller due to Purge Pressure Issues

The OCE PFDD program fosters collaboration between FDA centers and external stakeholders involved in patient outcomes research in cancer populations.

Bioresearch Monitoring Information System (BMIS) background page with download file.

Section 505B(d)(1) requires FDA to send a PREA Non-Compliance letter to sponsors who have failed to submit their pediatric assessments required under PREA by the final due date, have failed to seek or obtain a deferral or deferral extension.

Inotiv Inc. – 10/24/2025. Country: United States. Record Type: 483

Medispray Laboratories Private Limited – 01/20/2025. Country: India. Record Type: 483