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 | July 7, 2019

Among the most important announcements this week is that the FDA and EMA Mutual Recognition Agreement is now fully active.  This has been in the works, in many iterations for a long time!  One of the benefits will be that’s firms do not need to retest covered products upon their shipment from the US to EU countries!  In the non-guidance publications section we include a press release and a Q&A.  For the testing upon import, please reference Question 10. [...]

By |July 16th, 2019|Categories: Weekly Scans|0 Comments

Special Reports

May 22nd, 2019|0 Comments

An evaluation of warning letters associated with data governance and data integrity deficiencies. In this summary, we identify: • [...]

January 22nd, 2019|0 Comments

A detailed summary of the drug GMP warning letters issued in FY2018, as well as a comparison of trends [...]

January 8th, 2019|0 Comments

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

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