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?

4. 5 Barriers To Blockchain Adoption In The Rx Supply Chain — And How To Overcome Them 9/11/2019

   Blockchain has already started to find fit-for-purpose use cases in the pharmaceutical industry. Some of the largest pharma companies in the world are now conducting pilots and are expected to move towards production cases in the coming year. But for blockchain to succeed, several remaining obstacles must still be overcome.

5. DSCSA’s 2023 Interoperability Requirements: Don’t Just Check The Compliance Box 6/27/2019

   The Drug Supply Chain Security Act (DSCSA) requires creation of an interoperable system by 2023 to facilitate the sharing and gathering of transactional information back to the packaging at the original manufacturer for authorized trading partners or government agents in the event of a suspicious or illegitimate product. How will this system work and what components and governance will be required?