Monthly Archives: September 2019


WEEKLY SCAN | September 15, 2019

A busy week for the FDA in their publication of guidance.  Devices and generics were among the most active.  MHRA, ICH and WHO also published one guidance each.  The non-guidance collection includes a blog entry from the MHRA,  their update on 2017 and 2018 GLP deficiencies and another FDA update on the ‘sartan’ recalls.  See also the actions that [...]

By |2019-09-24T13:15:36+00:00September 24th, 2019|Weekly Scans|

WEEKLY SCAN | September 8, 2019

Thanks for your patience with my vacation, but we’re all back to work again! I’ve picked up many of the published guidance that appeared in my absence, CDRH was busy,  but I may have missed one or two. Four of the CDRH guidance address the 510(k) program, three address de novo classification and the remaining two address the humanitarian [...]

By |2019-09-17T14:28:51+00:00September 17th, 2019|Weekly Scans|

MONTHLY SCAN | August, 2019

Happy Reading, Barbara FDA: ADMINISTRATIVE: The FR announced a public docket to collect comments on evaluating the clinical pharmacology of oligonucleotide Biologics: The FR announced the availability of the Agency’s annual report “Report on the Performance of Drug and Biologics Firms in Conducting Postmarketing Requirements and Commitments.” DRUGS: The FR announced the availability of a final guidance for [...]

By |2019-09-05T11:48:56+00:00September 5th, 2019|Monthly Scans|

WEEKLY SCAN | August 25, 2019

NOTE:  There will be no newsletter published on Tuesday September 10 due to Barb’s vacation the previous week in areas without connectivity.  Great scenery and hiking, but no/limited internet. Once again we have a sparse week on the guidance front, with two items from FDA.  The non-guidance items however continue though there are fewer of them also.  End of [...]

By |2019-09-03T11:44:42+00:00September 3rd, 2019|Weekly Scans|