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 | January 12, 2020

Nothing in the way of relevant FR announcements or new information from EMA on guidance or changes this week. The non-guidance section includes an FDA preliminary listing of the biologics NDA that will become BLAs in March 2020.  Three more products were just added due to language inserted in the appropriations bill that passed Congress in December 2019. A couple of the Editors Choice, Stories of the Week are worth at least a quick look.  One is from PharmaCompass, [...]

By |January 21st, 2020|Categories: Weekly Scans|Comments Off on WEEKLY SCAN | January 12, 2020

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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