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 | September 9, 2018

FDA was busy on the guidance/rule publication front this week.  Four publications addressed devices and two focused on Quality.  Among the later, the most relevant may be the draft guidance on post-approval changes to drug substance.  Because this draft guidance addresses  APIs supported by DMF filings, it would be interesting to consider whether any of these new requirements MAY have served to identify the current impurity in the Valsartan drug substance.  Just a thought, the timing here is curious.  [...]

By | September 18th, 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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