CY2017 data integrity drug GMP warning letters and trends from the past ten years including drug warning letters with data integrity deficiencies, number of data integrity associated warning letters by country, geographic totals and percentage, and regulations cited in 2017 data integrity associated drug warning letters.
Laws, Regulations, Guidance, and Concept Papers FDA published 6 draft guidance addressing a variety of gene therapy issues. These cover a range of topics and
FDA posted 6 warning letters this week, including 1 to a finished pharma firm, 1 to an API manufacturer, and 1 to a compounding pharmacy.
Laws, Regulations, Guidance, and Concept Papers Just a few guidance documents and updates on non-guidance documents. To see the complete list of laws, regulations, guidance,
This is a particularly spare week for warning letter publication. There is only 1 to an API manufacturer, and we cover it below. Want to
Laws, Regulations, Guidance, and Concept Papers: Guidance documents this week were from the FDA, EMA, and HPRA. Among the FDA ones are 2 programs where
FDA posted 15 warning letters this week — many issued by the Center for Tobacco Products, and 3 issued for firms in the areas we
This Special Report represents the 3rd year that we have published an evaluation of warning letters associated with data governance and data integrity deficiencies. Failures
Laws, Regulations, Guidance, and Concept Papers: Lots of PIC/S guidance this week along with a couple from the FDA and EMA and 1 each from