Contributing Editors

  1. This Takeda Official Thinks Pharma 4.0 Won't Be Optional Much Longer 8/14/2024

    Advanced technology like automation was once seen only as a competitive advantage. That viewpoint is shifting amid greater reliance on digital technology.

  2. 2024 Emerging Trends In Cleanroom Technologies 8/14/2024

    This article shares new market research on pharma/biotech cleanroom technologies, including regional trends, prominent vendors in the space, and more.

  3. VR/XR In Drug Manufacturing: No Longer Sci-Fi 8/13/2024

    Virtual reality (VR) immerses users in a completely simulated environment, while extended reality (XR) is an umbrella term encompassing VR, augmented reality, and mixed reality. These capabilities open up a world of possibilities for drug manufacturing.

  4. Bacterial Endotoxin Testing, Part 4: Key Tests For Endotoxin Detection 8/7/2024

    This article concludes the author's series on bacterial endotoxin testing. It discusses best practices for the labeled lysate sensitivity test, non-interfering dilution determination, and more.

  5. The Learned Intermediary Doctrine Sees Curious Change In California 8/5/2024

    U.S. courts have long recognized the learned intermediary doctrine, which holds that a manufacturer of a prescription medication or medical device discharges its duty to warn by providing an adequate warning to the doctor. In the recent Himes v. Somatics, LLC, the California Supreme Court may have opened the door to this argument. 

  6. DSCSA Implementation Is Progressing, But More Complexity May Be Coming 8/5/2024

    The FDA recently announced it would exempt small dispensers from requirements of the Drug Supply Chain Security Act (DSCSA) until Nov. 27, 2026. The industry has made tremendous progress so far with DSCSA, but this discretion will make compliance more challenging.

  7. 2023–2024 Trends In FDA Form 483s For Pharmaceutical Formulation Facilities 8/1/2024

    A comprehensive review of FDA observations from small molecule drug facilities sheds light on the state of compliance and regulatory practices in the pharma industry.

  8. The Real Cost Of Poor Quality — And What You Should Do About It 7/30/2024

    It is well recognized that poor quality can lead to supply disruption. To drive positive change, the sector should seek to greater enhance quality maturity.

  9. Bacterial Endotoxin Testing, Part 3: Calculating Endotoxin Limits & MVD 7/30/2024

    The author continues his article series on bacterial endotoxin testing by discussing depyrogenation and calculating endotoxin limits and maximum valid dilution (MVD), including those for active substances and excipients, combination products, and medical devices.

  10. FDA Finalizes Guidance About Delaying, Denying, Limiting, Or Refusing An Inspection 7/25/2024

    The FDA has finalized a guidance on the circumstances that constitute delaying, denying, limiting, or refusing a drug or device inspection. The agency also provides reasons that may cause drugs or devices to be adulterated under the FD&C Act.