Guest Columns

81. 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. 

82. 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.

83. 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.

84. Is Your Lab Ready For A LIMS Implementation? 7/25/2024

    Deploying a laboratory information management system (LIMS) can boost your quality control lab's productivity, but how are you going about it? This article shares key steps and considerations for setting up your physical lab, controlling inventory, and more.

85. Bacterial Endotoxin Testing, Part 2: Prerequisites & Reagent Preparation 7/23/2024

    In this second article of a planned series about bacterial endotoxin testing, the author shares best practices about prerequisites and reagent preparation for a gel clot Limulus amebocyte lysate (LAL) test.

86. How Early Talks With The FDA Can Pave Your DTx Approval Pathway 7/22/2024

    Consultant Acacia Parks discusses when and how DTx developers should work with the FDA to improve their overall development and clinical trial processes.

87. Making Good Decisions When FDA Investigators Come Knocking 7/18/2024

    Ready or not, when the FDA inspector arrives, the test has already started. New final guidance makes clear what the agency considers an attempt to stonewall.

88. Answer These Questions To Guide Your Prototyping Strategy 7/18/2024

    This article shares key questions for your team to ask yourselves about demonstrating proof-of-concept with a functional prototype of your medical device.

89. 5 Recommendations To Maximize CSV/CSA Outcomes 7/17/2024

    The computer system validation (CSV)/computer system assurance (CSA) process is correlated with other departments besides IT and quality. Accordingly, all stakeholders must think ahead and define what they need.

90. Bacterial Endotoxin Testing, Part 1: Overview 7/16/2024

    All injectable drug products and implantable medical devices that come into contact with the bloodstream or spinal fluid are tested for endotoxins. This article provides an overview of bacterial endotoxin testing and the LAL method.