FDAzilla GMP Regulatory Intelligence Newsletter

FDAzilla GMP Regulatory Intelligence Newsletter
FDAzilla GMP Regulatory Intelligence Newsletter2018-04-02T01:58:47+00:00

Latest Issue

WEEKLY SCAN | January 6, 2019

The FDA is still mostly furloughed except for safety issues.  Others are back on a more normal post-holiday work effort. Nothing from the EMA or FDA in terms of guidance but a handful from TGA. Non-guidance items include those from MHRA, EMA, FDA, ICH and HPRA.  We provide one warning letter issued to the Akorn Inc facility in Decatur IL. There were three unclassified recalls and one classified drug recall, along with one import alert among those we follow.  [...]

By |January 15th, 2019|Categories: Weekly Scans|0 Comments

Special Reports

January 8th, 2019|0 Comments

RISK FACTORS USED IN SCHEDULING FDA DRUG GMP INSPECTIONS The global supply chain for drug products sold in the [...]

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. [...]

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