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The US Food and Drug Administration (FDA) has historically developed mechanisms to expedite its review of innovative therapies. In December 2025, the agency outlined tenets of the plausible mechanism framework, intended to provide regulatory guidance when randomized controlled trials are not practical. It issued draft guidance on those tenets in February 2026. This article summarizes the FDA’s guidance on requirements for the approval of individualized therapies targeting specific conditions with known biological causes from an industry perspective.

This article discusses the current landscape of laboratory-developed tests (LDTs) following a federal court’s decision to vacate the FDA’s final rule, which represented the agency’s latest attempt to regulate this category of in vitro diagnostic (IVD) products. This article explores the history of the FDA’s efforts to regulate these tests, past and current enforcement trends, and best practices for developers and manufacturers to protect against compliance pitfalls.

Live biotherapeutic products are an emerging class of biological medicines that rely on viable microorganisms to treat or prevent disease. Unlike probiotics marketed as foods or dietary supplements, live biotherapeutic products are regulated as drugs and are therefore subject to rigorous requirements for quality, safety, and clinical efficacy. Recent approvals of microbiota-based treatments for recurrent Clostridioides difficile (C difficile) infection, a bacterial illness that causes severe diarrhea, highlight their therapeutic potential and the regulatory challenges posed by using living organisms. This article examines regulatory expectations for live biotherapeutic products in the US and EU, with an emphasis on safety evaluation, clinical development strategies, and manufacturing controls.

As medical device innovation accelerates and regulatory requirements grow more complex, medtech companies face operational challenges in scaling their regulatory affairs (RA) functions. RA teams, which have historically been underfunded, must handle more activity with the same number of employees. This article examines the ensuing challenges RA teams face in bringing new products to markets and how using technology to manage regulatory information can help centralize information, structure documentation and data, and standardize and streamline workflows. The article emphasizes the importance of training and upskilling programs and shifting from reactive, manual processes to integrated, proactive systems.

Pediatric plans are regulatory frameworks ensuring that the well-being of the pediatric population is adequately considered during the development of new medicinal products. With global harmonization, regulatory writing becomes critical in drafting compliant, ethical, and scientifically robust pediatric study strategies. This article provides an overview of the differences in pediatric plan requirements across the European Medicines Agency (EMA), Japan’s Pharmaceuticals and Medical Devices Agency (PMDA), and the US Food and Drug Administration (FDA), highlighting the regulatory submission process, writing considerations, and common challenges encountered during plan development.