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15 Sep 2026

The proposed plausible mechanism framework: Potential promises and challenges

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 It issued draft guidance on those tenets in February 2026.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.

Journal
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15 Sep 2026

Diagnostics in limbo: Evaluating the new lab-developed test compliance landscape

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.

Journal
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15 Sep 2026

Journal of Regulatory Affairs, September-October 2026

Welcome to the Journal of Regulatory Affairs, featuring articles on the proposed plausible mechanism framework, essential drug delivery output control strategies for drug/biologic combination products, the new lab-developed test compliance landscape for diagnostics, the use of real-world evidence in FDA medical device submissions, and pediatric frameworks in the US and EU.

Journal
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14 Sep 2026

EMA reports on international API inspection sharing effort

A recent report from the European Medicines Agency (EMA) highlights that global regulators are strongly committed to sharing plans for good manufacturing practice (GMP) inspections of active pharmaceutical ingredient (API) suppliers yet have made only moderate progress toward sharing inspection reports in recent years. Joint inspections remain a challenging area, evidenced by a 50% decrease compared to the previous reporting period.

Regulatory News
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