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 | May 13, 2019

This week saw a few guidance documents, three from FDA and one from WHO.  Nothing from Europe in the areas we follow.  The non-guidance group has the usual collection from FDA, EMA, MHRA and HPRA. Some interesting reading in the collection. Enforcement included five warning letters to either homeopathic or OTC firms continuing the FDA’s focus in this area that we saw begin in 2017 and really ramp up in 2018.  It appears that they have implemented enforcement against [...]

By |May 21st, 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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