April 10, 2023 FDA ESG Digital Certificates If you are having trouble getting FDA’s ESG portal to work for you because of rejected digital certificates, then there there are at least a couple of alternatives. Specifically, you can seek expert third party assistance getting your digital certificate issues resolved; and/or in the meantime while […]
<h1 class="entry-title">Category: Adverse Events</h1>
So Many Adverse Event Reporting Terms in Various Jurisdictions
April 4, 2023 So Many Adverse Event Reporting Terms in Various Jurisdictions I’ve seen companies try to combine multiple jurisdictions’ adverse event reporting requirements into a single universal set of criteria and terminology. But that approach inevitably leads to under-reporting or over-reporting in certain jurisdictions. Accordingly, my generally preferred approach is to keep the […]