Monthly Archives: April 2018


WEEKLY SCAN | April 15, 2018

FDA published several new guidance, both draft and final, this week.  Two are administrative and two address Quality and one addresses format for submission of vaccines data. The FDA published ICH Q&A regarding Q7 is excellent; it includes just under 60 questions and an appendix that links each Q&A to the section of Q7.  TGA published two relevant items. [...]

By |2018-04-24T14:56:12+00:00April 23rd, 2018|Weekly Scans|

WEEKLY SCAN | April 8, 2018

A bit of a busier week than last week for guidance.  The FDA published six documents, nothing from EMA in the areas we follow.  WHO, CDSCO, Health Canada, TGA and HPRA also published guidance. Non-guidance publications from the usual sources, MHRA, EMA, FDA and we include one each from TGA and PMDA. Enforcement is still a bit light with [...]

By |2018-04-17T13:47:06+00:00April 16th, 2018|Weekly Scans|

SPECIAL REPORT: MHRA Data Integrity Guidance, 2015 and 2018

MHRA published a revision to their 2015 Data Integrity Guidance, finalizing the draft revision published for consultation in 2016.  The MHRA Inspectorate blog says that the health authority received over 1300 comments during the consultation process. The revision was a coordinated effort among the GCP, GDP, GLP, GMP and GPvP inspection groups reflecting a broad source of input.  MHRA specifically, [...]

By |2018-04-10T18:58:29+00:00April 10th, 2018|Special Reports|

WEEKLY SCAN | April 1, 2018

It’s been a slow week all around, perhaps spring breaks and the holidays?  We include another special this week, this one on the recently published MHRA 2018 Guidance on Data Integrity. [View the SPECIAL REPORT: MHRA 2018 Guidance on Data Integrity] Among the non-guidance publications, CFDA published an update on their 2017 Review Metrics. A very slow enforcement week, [...]

By |2018-04-13T12:39:51+00:00April 10th, 2018|Weekly Scans|

MONTHLY SCAN | March, 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 [...]

By |2018-04-03T16:23:54+00:00April 2nd, 2018|Monthly Scans|

WEEKLY SCAN | March 25, 2018

A slow week for guidance publication, two from FDA and one from WHO.  The non-guidance area saw the usual collection from EMA, MHRA, FDA and one each from MHRA and TGA. Enforcement included two warning letters to drug manufacturers, two warning letters to compounding pharmacies, and FDA released two form 483s issued to sites in India. We see the [...]

By |2018-04-13T12:42:06+00:00April 2nd, 2018|Weekly Scans|