Monthly Archives: March 2018


WEEKLY SCAN | March 18, 2018

We have another slow week in the publication of guidance.  FDA published two addressing post approval safety reporting for combination products and one regarding drug compounding.  EMA published one item addressing pharmacogenomic practice. CDSCO (India) and TGA each published one. We see the usual collection of non-guidance items from MHRA, EMA, FDA and HPRA this week. This includes two [...]

By |2018-04-03T16:25:31+00:00March 26th, 2018|Weekly Scans|

WEEKLY SCAN | March 11, 2018

Time here for another special supplement, this one on drug data governance / data integrity warning letters issued in CY2017.  We trend warning letters on this topic over the past 10 years, identify the most common predicate rules cited in 2017 warning letters, and evaluate the countries where most of these sites are located.  We also include the text of [...]

By |2018-04-03T16:27:24+00:00March 16th, 2018|Weekly Scans|

SPECIAL REPORT: Drug GMP Warning Letters Data Governance and Data Integrity

This Special Report represents the third year that we have published an evaluation of warning letters associated with data governance and data integrity deficiencies. Failures in data integrity and data governance is an enforcement area that began almost twenty years ago and continues to increase in visibility and number of warning letter enforcement actions. FDA is not the only health [...]

By |2018-04-01T21:11:03+00:00March 15th, 2018|Special Reports|

WEEKLY SCAN | March 4, 2018 

It was a light week on the guidance front particularly from the EMA and the FDA.  On the other hand, WHO published two drafts, Health Canada published a final revision to their drug GMPs, and perhaps more important than all (I admit I’m prejudiced on the topic) is the final version of the MHRA GXP Guidance on Data Integrity. The non-guidance publication was [...]

By |2018-04-03T16:29:03+00:00March 12th, 2018|Weekly Scans|