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 | November 4, 2018

From the fire area of Thousand Oaks CA, the firefighters are loved here and with good reason!  Truly exceptional people to whom we owe our gratitude. A few guidance documents from FDA, EMA and CDSCO.  Some good reading.   The usual group of non-guidance from the FDA, EMA, MHRA, HPRA and TGA this week. Enforcement again this week is slow except form 483s received by compounding pharmacies and outsourcing facilities.  Also, we provide a link to an article that supplier [...]

By | November 13th, 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

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