Regulatory Focus

BETHESDA, MD – Sarah Yim, director of the US Food and Drug Administration’s (FDA) Office of Therapeutic Biologics and Biosimilars in the Office of New Drugs, emphasized that the agency is actively working to help sponsors reduce their reliance on clinical efficacy studies to demonstrate that a new biosimilar is comparable to its reference drug and to build public confidence in biosimilars.

BETHESDA, MD – A top US Food and Drug Administration (FDA) enforcement official announced that the agency conducted more unannounced drug inspections in India and China in FY 2026 compared to the previous year.

More than 500 comments have been submitted in response to the US Food and Drug Administration’s (FDA) discussion paper on generative AI (genAI)-enabled medical devices, and stakeholders have offered the agency a wide variety of advice on the best way to regulate these technologies.

BARCELONA – Navigating Europe’s complex environmental and sustainability legislation can be daunting, but healthcare product manufacturers can take concrete steps to ensure they remain compliant, according to two legal experts who spoke at RAPS Regulatory Intelligence Conference Europe on Tuesday.

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In a final guidance issued on Monday, the US Food and Drug Administration (FDA) laid out its expectations for cell and gene therapy (CGT) sponsors to demonstrate that their products meet potency standards through the developer a potency assurance strategy.

Patients who reviewed and signed a patient agreement form (PAF) for mifepristone and misoprostol under the US Food and Drug Administration’s (FDA) risk evaluation and mitigation strategy (REMS) program were equally knowledgeable about medication abortion compared to patients who completed a knowledge survey before reviewing and signing the PAF, according to the results of a recent randomized controlled trial published in JAMA Internal Medicine.

Australia’s Therapeutic Goods Administration (TGA) is holding consultations on information sharing under clinical trial schemes and its proposed comments on an international guideline for good clinical practice (GCP).