Monthly Archives: September 2019


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|