Regulatory Affairs Editorial

81. Avoid Launch Delays By Planning For An FDA-Required REMS 1/13/2023

    Picture this: The FDA accepts a manufacturer's NDA, and the manufacturer plans for its impending launch. But shortly before the anticipated approval, the FDA notifies the manufacturer that a Risk Evaluation and Mitigation Strategy (REMS) program is required to market the product. Now what?

82. FDA Adopts ICH Final Guidance On Bioanalytical Method Validation 1/11/2023

    The FDA has issued final guidance on the validation of biological assays, titled M10 Bioanalytical Method Validation and Study Sample Analysis. ICH approved the final guidance in May 2022, so this FDA adoption completes international acceptance of a unified approach. It extends to both full and partial validation for clinical and nonclinical studies.

83. How To Educate Regulators On What Matters To Patients 12/13/2022

    With the greater emphasis on patient-centricity, patients are valued as an active participant in their own care. There is an increased emphasis on evaluating treatment benefit using patient-centric concepts and input from the patient community. Regulators now urge sponsors and researchers to systematically engage patients and caregivers to define the disease burden and unmet needs.

84. 3 Tips To Navigate The Increasingly Complex PVA Landscape 12/8/2022

    The shifting landscape of industry innovation and unconventional partnerships has created a need for an increased number of pharmacovigilance agreements (PVAs) with higher levels of complexity. As a result, many stakeholders face new challenges in drafting, negotiating, and finalizing PVAs.

85. Needed: An AI Revolution In The Rare Disease Space 11/11/2022

    Quris has developed a treatment for Fragile-X Syndrome, the most common inherited cause of autism and intellectual disabilities worldwide. Isaac Bentwich M.D., the founder and CEO of Quris, believes the rare disease space, in general, is a difficult one to navigate.

86. LATAM’s Regulatory Framework For Medtech Early Feasibility Studies 11/11/2022

    Latin America is a compelling region to conduct medtech early feasibility studies due to its ethnically diverse population, its high rate of urbanization, and more. Here, the author spotlights Colombia, Brazil, and Mexico as the hotspots for medtech feasibility studies in Latin America. 

87. Survey Reveals High Levels Of CTIS Adoption In Europe 11/8/2022

    Early feedback from users of the EMA’s new centralized clinical trials information system (CTIS) is broadly positive, according to a survey of 400 U.S. and European life science leaders. CTIS use isn’t mandatory until after the end of January 2023, but industry uptake has already been strong.

88. India’s New Drugs, Medical Devices, And Cosmetics Draft Bill 2022 11/7/2022

    To accommodate changing requirements and encourage the adoption of new technology, India’s Ministry of Health and Family Welfare released a draft bill in July 2022 to replace the existing Drugs and Cosmetics Act 1940. What are the major areas of change and how much of an impact will there be?

89. Key Insights From The 2022 PDA/FDA Joint Regulatory Conference 11/3/2022

    Key focus of this article is spent on thoughts shared by the FDA speakers, including the importance of a quality infrastructure, sustainable compliance, data integrity, and more.

90. How To Optimize Returns On Plain Language Summaries 10/31/2022

    The EMA now requires Plain Language Summaries (PLS) for clinical trials with sites in the EU. The FDA has no current regulations for PLS, but they fit into recent guidance documents. PLS meet the needs of trial participants, their families, and patient advocacy groups, among others. Optimize your PLS with these tips.