Monthly Archives: November 2018


WEEKLY SCAN | November 18, 2018

I was all ready to explain away a short newsletter based on the long Thanksgiving holiday weekend in the US.  But no, this is a long one, with lots of warning letter action and an EU report of GMP non-compliance.  Four drug warning letters, including one to Mylan’s Morgantown WV site, and one to a device manufacturer were posted [...]

By |2018-11-27T14:59:14+00:00November 27th, 2018|Weekly Scans|

WEEKLY SCAN | November 11, 2018

This week has one guidance from FDA and two from EMA.  The one addressing pharmaceutical water quality is important for everyone to read, even though it is a draft.  IMDRF published three final documents, HPRA and New Zealand each published one.  We saw the usual collection of non-guidance documents from FDA, MHRA, EMA and others. FDA published one device [...]

By |2018-11-20T14:21:42+00:00November 19th, 2018|Weekly Scans|

WEEKLY SCAN | November 4, 2018

From the fire area of Thousand Oaks CA, the firefighters are loved here and with good reason!  Truly exceptional people to whom we owe our gratitude. A few guidance documents from FDA, EMA and CDSCO.  Some good reading.   The usual group of non-guidance from the FDA, EMA, MHRA, HPRA and TGA this week. Enforcement again this week is slow [...]

By |2018-11-13T19:39:45+00:00November 13th, 2018|Weekly Scans|

MONTHLY SCAN | October, 2018

Happy reading! Barbara FDA: GENERICS, transdermals: The FR announced availability of a revised draft guidance, ‘Assessing Adhesion with Transdermal and Topical Delivery Systems for Abbreviated New Drug Applications’ GENERICS, transdermals: The FR announced availability of a draft guidance  titled ‘Assessing the Irritation and Sensitization Potential of Transdermal and Topical Delivery Systems for ANDAs’ GENERICS: [...]

By |2018-11-08T20:53:36+00:00November 8th, 2018|Monthly Scans|

WEEKLY SCAN | October 28, 2018

A bit of a slow week on the guidance front, only three documents from the FDA and none from EMA or other jurisdictions.  On the non-guidance front, we have a collection from FDA, MHRA, TGA and HPRA, nothing from EMA this week. Enforcement includes GCP warning letters, four warning letters to device manufacturers that are located outside the US [...]

By |2018-11-06T11:37:21+00:00November 5th, 2018|Weekly Scans|