FDAzilla GMP Regulatory Intelligence Newsletter

FDAzilla GMP Regulatory Intelligence Newsletter
FDAzilla GMP Regulatory Intelligence Newsletter2019-01-24T16:12:39+00:00

Latest Issue

MONTHLY SCAN | November, 2019

Happy Reading, Barbara FDA: DEVICES: The FR announced the availability of final guidance published ‘Process to Request a Review of FDA’s Decision Not to Issue Certain Export Certificates for Devices’ .  The intent of the guidance is to provide transparency on the decision-making process for denial of a certificate and identifies how to request a review of the denial decision and how to contact FDA staff for questions. And HERE is the FDA Law Blog analysis. CBER SOPP [...]

By |December 5th, 2019|Categories: Monthly Scans|0 Comments

Special Reports

July 16th, 2018|0 Comments

Warning Letters for the First Half of 2018 This article summarizes warning letter enforcement actions in the first half of [...]

June 4th, 2018|0 Comments

The U.S. Food and Drug Administration (FDA) identified failures in data governance and data integrity starting approximately 20 years ago. [...]

  • FDA17 Enforcement Analytics Summary

June 4th, 2018|0 Comments

FDA Enforcement Statistics Summary, Seizures, Injunctions, Warning Letters, Total Recall Events, Total Recalled Products, Recalls

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