FDAzilla GMP Regulatory Intelligence Newsletter

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

Latest Issue

WEEKLY SCAN | August 4, 2019

A light week for guidance with two from FDA and none from EMA.  Health Canada published two and IMDRF published one.  We have the usual collection of non-guidance publication including MHRA Inspectorate blog posts. Very light on the warning letter front this week with only one warning letter and that was issued to yet another OTC firm, continuing the trend from last year.  More interesting though, is information provided by the FDA on a data integrity issue with a [...]

By |August 12th, 2019|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

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