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 | August 11, 2019

A light week for new guidance. FDA published two and that was it!  We have the usual complement of non-guidance publications from the MHRA, EMA, FDA and one from China. In the enforcement area we cover three drug warning letters, one issued to a compounding pharmacy, one device warning letter and one in the food area that is a ‘first of it’s kind’.  One of the drug warning  letters is issued to a firm that recovered solvents that were [...]

By |August 20th, 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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