Articles by Mike and Mark Karhoff

1. 6 Things We Need From FDA Before Full 2023 DSCSA Enforcement 1/6/2021

   This article suggests concrete actions the FDA can take to help unify a complex and diverse group of stakeholders prior to enforcing the full requirements of the Drug Supply Chain Security Act (DSCSA) in Nov. 2023.

2. Helping Pharma Manufacturers Overcome DSCSA Interoperability Pain Points 4/13/2020

   With the FDA guidance documents and requirements of the Drug Supply Chain Security Act still unfolding, there is a growing need for sectors in the supply chain to align on how to meet various aspects of the law.

3. Are You Ready For A DSCSA Audit? 5 Steps To Ensure The Answer Is “Yes” 3/16/2020

   During an FDA audit, you're asked questions about the U.S. Drug Supply Chain Security Act and how you offer and share your T3 data with downstream trading partners. Do you answer confidently, or hold your breath and gulp?