FDAzilla GMP Regulatory Intelligence Newsletter

FDAzilla GMP Regulatory Intelligence Newsletter
FDAzilla GMP Regulatory Intelligence Newsletter 2018-04-02T01:58:47+00:00

Latest Issue

WEEKLY SCAN | July 8, 2018

This week we include a brief supplement addressing warning letter enforcement actions taken in the first half of 2018. We will update this information, as we’ve done in the past few years, in a larger report at the end of the FDA fiscal year. On the guidance front, FDA published six draft guidance addressing a variety of gene therapy issues.  These cover a range of topics and have been promised by FDA.  Another two guidance were also published this [...]

By | July 17th, 2018|Categories: Weekly 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

Archive

error: Copying any content on this site is a violation of Copyright laws.