REGULATORY ARTICLES

  • Merck, Walmart, IBM, & KPMG’s FDA Blockchain Pilot: What We Learned

    IBM, KPMG, Merck & Co., and Walmart successfully completed an FDA pilot program that demonstrated how blockchain technology can be used to help meet the Drug Supply Chain Security Act (DSCSA) requirements to verify, track, and trace prescription medicines and vaccines distributed within the U.S. 

  • A Real-World Consulting Calamity — 6 Ways It Could Have Been Avoided

    Some leaders in the pharma, biopharma, and med device industries believe hiring consultants is quicker and more efficient than hiring a full-time employee. Does this thinking fail to factor in the investment required for thorough recruiting and training to ensure a successful engagement?

  • Are You Ready? FDA’s Transition From Computer System Validation To Computer Software Assurance

    The FDA is preparing to release new guidance, "Computer Software Assurance for Manufacturing, Operations and Quality Systems Software," in late 2020. This new guidance will provide guidelines for streamlining documentation with an emphasis on critical thinking, risk management, patient and product safety, data integrity, and quality assurance.

  • An Update On Regulatory Guidance For U.S. Clinical Trials During COVID-19

    To preserve integrity in clinical trials and mitigate the need to place clinical trials on hold indefinitely, the FDA has issued updated guidance to support important research and exploration of new treatments. Additionally, the U.S. Department of Health and Human Services’ Office of Human Research Protection issued guidance to assist researchers in applying human subject protection regulations.

  • Working With Two Consultants On One QMS Overhaul: What Could Go Wrong?

    Some companies in the life sciences mistakenly assume that if they hire multiple consulting firms to establish, manage, or overhaul a quality management system, it will inevitably result in an automatic licensure of their new blockbuster product at a low service cost. This article will discuss just such a scenario. 

  • Should You List All Manufacturing Facilities In Your Drug Application? A Question Of Regulatory Ethics

    In this second installment of a two-part article, we will review the importance of listing all appropriate manufacturing facilities in the drug substance section of a drug application and discuss the role of regulatory professionals in ensuring that the necessary information is included in the application.

  • Navigating The FDA’s Emergency Use Authorization Process

    The FDA has been authorized to grant Emergency Use Authorizations for SARS-CoV-2. This will impact both internal manufacturing and the CDMOs that drug sponsors employ. 

  • EMA Publishes 3 Noteworthy Updates Amidst Avalanche Of COVID-19 Communications

    While communications from health authorities continue to pour in regarding actions they are taking to mitigate the impact of the COVID-19 pandemic, the EMA published three new items that merit attention from the life sciences industry. Two of them result from the pandemic; the third has been under development.

  • Remote Auditing Best Practices For GMP Compliance

    Every organization that is regulated by the FDA has been adversely affected by the coronavirus (COVID-19) pandemic. This article will focus on remote auditing for good manufacturing practice (GMP) compliance, with a focus on the challenges, opportunities, and best practices for performing remote internal and external audits.

  • Facilitating Great Virtual Meetings During A Pandemic (Or Any Other Time)

    Even before the global pandemic of the novel coronavirus, virtual meetings were on the rise, With a large percentage of people working from home, it's now a public health imperative. Here's how to facilitate a risk assessment, root cause investigation, or something similar via “virtual facilitation” with team members and subject matter experts scattered around the world.