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 | March 10, 2019

A broad collection of guidance from FDA, EMA, MHRA, Health Canada and TGA.  This week saw a smaller than usual collection of non-guidance documents. Warning letters posted this week include ones demonstrating FDA’s continued focus on OTC product manufacturers,  and manufacturers in India including a particularly testy letter to Pfizer for a Hospira site in India that they are closing.  Lupin announced that they received a warning letter, but it has not been posted by the FDA yet.  This [...]

By |March 19th, 2019|Categories: Weekly Scans|0 Comments

Special Reports

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 [...]

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 [...]

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