Featured Pharma Online Editorial

  1. 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?

  2. The 5 Pillars Of Clinical Trial Material Management 2/25/2020

    Ensuring that enough study drug supplies are available at study sites is a requirement of every clinical trial. This article discusses five fundamental tools and techniques for effective planning, execution, monitoring, and inventory control of clinical trial material from the manufacturing, packaging, and distribution perspectives.

  3. 2nd Draft Guidance Under DSCSA Offers Clarity For 3PLs As January Deadline Approaches 10/28/2014

    Earlier this month, the FDA announced the availability of the second draft guidance under the Drug Supply Chain Security Act (DSCSA), titled The Effect of Section 585 of the FD&C Act on Drug Product Tracing and Wholesale Drug Distributor and Third-Party Logistics Provider Licensing Standards and Requirements: Questions and Answers. While clarifying information is provided, the guidance is still in draft form and more information from industry will need to be collected in order to drive it to a finalized state.