In 2020, most things did not go as planned. Considering the overwhelming impact of the worldwide pandemic, the pharmaceutical industry was far from immune to last year’s instability. One of the major changes came with the Saleable Returns Verification’s extension. Despite being originally scheduled for a 2020 enactment, the FDA recently announced their plan to … Continue reading Why the FDA Extended The Saleable Returns Verification from 2020 to 2023
FDA delays one wholesaler requirement, plus, Ilisa Bernstein leaves FDA
Could the FDA delay enforcement of the wholesaler’s 2019 DSCSA requirements?
Here are some resources for meeting wholesaler requests for their DSCSA obligations.
HDA responds to FDA’s draft guidance on Verification Systems. A must-read.
Most companies will do verification wrong, because they haven’t read the DSCSA or FDA draft guidance…or RxTrace.
GS1’s new standard for verification messaging. Does it apply to you? Probably.
Verification Systems under the DSCSA are the things that FDA (and probably state) inspectors are going to look for whenever they visit your facilities from now on. Are you ready? This new draft guidance will help you.