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 | February 3, 2019

Seems we are back to normal with FDA back up and in business with five publications this week.  Two addressed devices, two focused on safety one on combination products and one was administrative. ICH and WHO each published one and HPRA published two documents. Enforcement was back in full swing with three drug GMP warning letters this week.  Once again OTC manufacturers are FDA’s target.  A collection of recalls and a few import alerts round out the enforcement front. [...]

By |February 11th, 2019|Categories: Weekly Scans|0 Comments

Special Reports

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

  • Integrity Guidance

April 10th, 2018|0 Comments

MHRA published a revision to their 2015 Data Integrity Guidance, finalizing the draft revision published for consultation in 2016.  The [...]

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