Featured Pharma Online Editorial

  1. WHO's 6 Principles For An AI Regulatory Framework For Medical Product Development 12/14/2023

    In mid-Oct. 2023, the WHO published a paper titled Regulatory Considerations on Artificial Intelligence for Health, identifying the key principles that international regulatory frameworks for artificial intelligence (AI) should address and are, in fact, starting to coalesce around. The paper was developed in consultation with a WHO Working Group whose members include regulatory authorities, policy makers, and more.

  2. Outsourcing And Phase-Appropriate GMP For Clinical Manufacturing Needs 11/20/2023

    Appropriate manufacturing and timely delivery of investigational products are essential for the successful execution of clinical trials. This article shares best practices working with CDMOs as well as phase-appropriate GMP of the clinical supply.

  3. Leveraging An Application Managed Services (AMS) Provider For Pharma/Biotech Serialization Systems 11/16/2023

    With the expansion of serialization requirements, including the need for Drug Supply Chain Security Act compliance, many pharma/biotech companies are turning to serialization technology systems to help them manage those specifications. This article shares the key benefits of leveraging an application managed services (AMS) provider as well as key considerations for selecting a provider.

  4. 1 More Year For DSCSA Prep: Pros, Cons, & What To Do Next 10/30/2023

    The FDA recently announced that they do not intend to take action to enforce drug distribution security requirements under section 82(g)(1) of the FD&C Act until Nov. 27, 2024. What are the pros and cons of this announcement, and what should we do now? This expert shares his perspective and recommendations.

  5. FDA Announces 1-Year “Stabilization” Period For DSCSA Compliance — Don't Mistake It For An Enforcement Delay 10/4/2023

    On August 30 in a new guidance document, the FDA announced the establishment of a one-year stabilization period with regard to the enhanced security and unit-level electronic traceability requirements of the Drug Supply Chain Security Act (DSCSA) that go into effect on Nov. 27, 2023. The FDA makes it clear that this is not an opportunity to delay implementation; rather, it is an opportunity to refine, improve, and stabilize your systems and processes.

  6. 7 Improvements in Clinical Supply Chain Management Your CFO Will Love 10/2/2023

    There is a great opportunity for clinical supply chain practitioners to learn from their commercial peers. By adapting and adopting the right commercial best practices, clinical supply chains become more effective, cost-efficient, and agile in delivering the right treatments to the right patients.

  7. FDA Gives More Time To Comply With Certain DSCSA Requirements 9/27/2023

    To the relief of pharmaceutical companies and their trading partners, the FDA has paused enforcement of some Drug Supply Chain Security Act requirements. The agency warns that it's not an excuse to delay compliance.

  8. FDA Issues Second DSCSA Warning Letter — What Does This Mean? 8/16/2023

    In June 2023, shortly before final requirements of the Drug Supply Chain Security Act (DSCSA) must be met come November, the FDA issued a warning letter to Safe Chain Solutions, LLC addressing DSCSA violations related to repeated instances of distributing costly counterfeit antiviral drugs that Safe Chain had sourced from unauthorized trading partners. Let's look more closely at the emerging themes so that you can avoid a similar warning letter.

  9. Financial Leadership Of Strategic Procurement: 4 Foundational Steps 8/2/2023

    Efficiently managing a diverse supply base is crucial for drug companies to maintain growth, profitability, and compliance. While the procurement function can be organized under various executives, the relationship between the CFO, procurement, legal, and buying departments is very important.

  10. Practical — And Crucial — Actions To Take Now For DSCSA Compliance 6/29/2023

    Serialized data exchange, enhanced verification, and tracing, oh my! Many companies are still unprepared for full DSCSA implementation in November. Is your company one of them? Here are the important actions to take now.