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71. FDA Finalizes Guidance On Nonclinical Evaluation Of Pharmaceutical Immunotoxicity 7/18/2023

    The FDA has now finalized a guidance document on the immunotoxic potential of pharmaceuticals. The FDA builds on current ICH guidance and proposes a two-stage approach. Central to the guidance is using a risk framework.

72. Biocompatibility Testing Tips To Speed Your Medical Device To Market 7/12/2023

    Biocompatibility testing is a regulatory safety requirement that assures a device and its components are compatible with the biologic environment in which the device will be used. Maintain your critical path to market with these tips.

73. Agile Software Development In Bio/Pharma & Medical Devices, Part 2 7/11/2023

    Part 1 of this article series dived into the use of Agile methodology with a focus on the planning phase of a software development plan. This article dives further and discusses the phases of team structure and collaboration, defining requirements and product definition, software architecture, and more.

74. Key Considerations In Selecting A Robotic Solution For Endotoxin Testing 7/6/2023

    The U.S., European, and Japanese Pharmacopoeias require testing for bacterial endotoxin in pharmaceutical products, water, intermediates, and medical devices. This article shares key criteria for those of us who are looking to select an automated/robotic endotoxin detection system.

75. Key Post-Pandemic Trends In Global FDA Observations For Drug Facilities 6/29/2023

    These authors undertook a meticulous analysis of FDA drug facility inspection data spanning from July 2021 through May 2023. The resultant trend insights provide powerful resources for understanding areas of regulatory focus and a benchmark for evaluating potential vulnerabilities.

76. Cleaning Process Development: Using Design Of Experiments To Determine Critical Process Parameters 6/28/2023

    ASTM E3106 emphasizes that cleaning agents and cleaning processes should not be adopted randomly, nor should they be chosen simply based on what has been used in the past. In this article, part of the Cleaning Validation For The 21st Century series, let's look at which cleaning parameters are critical and what are the optimal cleaning parameter settings, through the lens of design of experiments (DoE).

77. Agile Software Development In Bio/Pharma & Medical Devices, Part 1 6/27/2023

    Under the FDA and other regulatory bodies, the bio/pharma and medical device industries have been using computer software/systems validation testing methodologies to validate software within the GxP environment. Let's dive into the use of Agile methodology in the planning phase of a software development plan.

78. An Agile Approach To Regulatory Information Management System Transformation 6/20/2023

    Life sciences industry regulators have become increasingly focused on data-driven processes as a means of managing marketing authorization submissions. But this requires that your regulatory information management system (RIMS) upgrades are in a state of continuous evolution and are approached holistically. 

79. Perfused Organ Models: An Alternative To Animal Testing 6/6/2023

    Animal testing has been a long-standing practice in biomedical research, providing valuable insights into disease mechanisms, drug efficacy, and safety. However, ethical concerns, limitations of animal models, and increasing awareness of animal welfare have prompted the development of alternative methods — like perfused organ models (POMs).

80. FDA Adopts ICH Guidance On Assessing Nonclinical Biodistribution Of Gene Therapy Viral Vectors 5/23/2023

    An important step in the gene therapy development process is assembling biodistribution data in suitable animals in relation to the intended clinical population. Developing an accurate biodistribution profile is influenced by factors such as the route of administration, dose level(s), dosing regimen, and the animal immune response to the gene therapy product. The FDA adopted this ICH guidance in May 2023, and the EMA plans to adopt it in September 2023.