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 | April 7, 2019

One final rule from FDA and a variety of updated items from the EMA, three items from WHO and one from Canada.  A collection of reading for the week.   We have the usual collection of non-guidance items from FDA, EMA, MHRA, HPRA. Enforcement was a bit slow with no drug or device GMP warning letters except for two issued to compounding pharmacies.  Still no evidence of the awaited Lupin warning letter.  We provide one form 483 from a recent [...]

By |April 15th, 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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