Monthly Archives: July 2019


WEEKLY SCAN | July 21, 2019

FDA posted one final guidance, an important one on post approval safety reporting for combination products.  EMA had none but Health Canada, France, WHO, TGA and CDSCO each had one. In the enforcement section, note a CRL issued for problems with the manufacturer of the API used in a bioequivalence study.   This is different from the API manufacturer of [...]

By |2019-07-30T12:37:57+00:00July 30th, 2019|Weekly Scans|

WEEKLY SCAN | July 14, 2019

This week has a complement of guidance from the FDA, EMA, IMDRF, ANVISA and TGA.  Everyone is busy.  We have a smaller than usual group of non-guidance documents from EMA, FDA, HPRA and MRA. In enforcement, the FDA published three drug warning letters this week, one of which was issued in April.  The warning letter to Strides Pharma Science [...]

By |2019-07-23T13:33:07+00:00July 23rd, 2019|Weekly Scans|

WEEKLY SCAN | July 7, 2019

Among the most important announcements this week is that the FDA and EMA Mutual Recognition Agreement is now fully active.  This has been in the works, in many iterations for a long time!  One of the benefits will be that’s firms do not need to retest covered products upon their shipment from the US to EU countries!  In the [...]

By |2019-07-16T13:00:33+00:00July 16th, 2019|Weekly Scans|

MONTHLY SCAN | June, 2019

Happy Reading, Barbara FDA: CLINICAL: The FR published availability of a draft guidance ‘Enhancing the Diversity of Clinical Trial Populations – Eligibility Criteria, Enrollment Practices, and Trial Designs’ CLINICAL: The FR announced the availability of a draft guidance ‘Treatment for Heart Failure:  Endpoints for Drug Development.’  FDA is hoping this will spur the development of new treatments for [...]

By |2019-07-12T04:20:26+00:00July 12th, 2019|Monthly Scans|

WEEKLY SCAN | June 30, 2019

A really busy week that I thought might be quiet because of the July 4 holiday in the US.  I was so wrong!  Lots of guidance from the FDA, EMA/EC, TGA, Health Canada, CDSCO, and IMDRF.  We also have the usual collection of non-guidance documents. Warning letter enforcement includes five drug warning letters published this week, two of which [...]

By |2019-07-09T15:05:31+00:00July 9th, 2019|Weekly Scans|

WEEKLY SCAN | June 23, 2019

After a few slow weeks, this was a busy one for guidance and a proposed rule publication from FDA.  Among the group, two are ICH guidance available for comment, and one is a proposed rule implementing features of the BPCI Act of 2009.  The EMA published clinical guidance and an Aide Memoire addressing inspection of safety features required by [...]

By |2019-07-02T18:19:21+00:00July 2nd, 2019|Weekly Scans|