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HDA responds to FDA’s draft guidance on Verification Systems.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Most companies will do verification wrong, because they haven’t read the DSCSA or FDA draft guidance…or RxTrace.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 This new draft guidance will help you.
Verification is arguably the most important concept in drug serialization and tracing regulations. What makes it so hard to get right?
Should the US pharma supply chain stakeholders create a National Medicines Verification Organization like the EMVO?