Monthly Archives: January 2018


WEEKLY SCAN | January 28, 2018

We published a special on drug GMP warning letters for FY2017 in the October 29, 2017 issue of the newsletter.  This week we publish another special addressing the most recently published drug product inspection observation data from FDA and MHRA. [SPECIAL REPORT: FDA and MHRA Most Recent DFA Drug Inspection Observations] Both FDA and EMA were busy on the guidance publication front [...]

By |2018-04-03T16:37:33+00:00January 28th, 2018|Weekly Scans|

WEEKLY SCAN | January 21, 2018 

Only four guidance documents were published this week, three from FDA and one from TGA.  The EMA didn’t publish guidance in the areas we follow this week.  The collection of non-guidance publications this week included items from MHRA, EMA, FDA and IMDRF.  It’s worth skimming through the list, EMA had a large collection! It was a busy week for published enforcement actions for [...]

By |2018-04-04T15:56:59+00:00January 21st, 2018|Weekly Scans|

WEEKLY SCAN | January 14, 2018 

With only a four-day work week in the US following a national holiday on Monday, FDA was busy publishing guidance in the remainder of the week.  Two of the more interesting are final guidance relevant for compounding pharmacies and outsourcing facilities reflecting FDA’s efforts to clarify requirements and ‘assist’ them in coming into compliance with the associated FD&C Act amendments.  The [...]

By |2018-04-04T16:00:52+00:00January 14th, 2018|Weekly Scans|

WEEKLY SCAN | January 7, 2018 

An amazingly slow week for guidance publications, one from the EC in support of Annex 13 and one from FDA on compliance dates for UDI identification of some devices…and that’s it! Enforcement is a bit more active but only one drug warning letter and one device warning letter, four drug compounding forms 483.   More than a handful of import [...]

By |2018-04-04T16:02:17+00:00January 7th, 2018|Weekly Scans|

SUMMARY SCAN, Week of January 1, 2018

Happy New Year and best wishes to all for a happy and productive 2018. Only a few new guidance published this week, a bit of a slowdown from previous weeks. A handful of publications from health authorities this week including the FDA published collection of FY 2017 inspection observations from the various product types that they regulate. Three drug [...]

By |2018-04-04T16:03:43+00:00January 1st, 2018|Weekly Scans|