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USFDA Med Dev Guidances: Intent to Exempt Certain Unclassified Medical Devices & Drug and Device Manufacturer Communications– Questions and Answers
Two notable guidance documents released in 2026 address distinct but equally important aspects of healthcare regulation. The first, Drug and Device Manufacturer Communications With Payors, Formulary Committees, and Similar Entities, provides updated recommendations regarding the communication of healthcare economic and clinical information between manufacturers and healthcare decision-makers. The second, Intent to Exempt Certain Unclassified Medical Devices from Premarket Not
Sharan Murugan
Jun 64 min read
USFDA Guidance: Leveraging Prior Knowledge in Genome Editing Gene Therapy Development
As genome editing technologies continue to advance, sponsors are increasingly developing innovative gene therapies targeting rare, serious, and life-threatening diseases. These programs often involve complex manufacturing processes, extensive nonclinical studies, sophisticated analytical testing, and lengthy clinical development timelines. To support more efficient development pathways, the FDA released the draft guidance, Leveraging Prior Knowledge in the Development of Huma
Sharan Murugan
Jun 63 min read
EMA EMA 2025 AI Observatory Report: Artificial Intelligence in Medicines Regulation
Artificial Intelligence (AI) is rapidly becoming an integral part of pharmaceutical development and regulatory operations. From drug discovery and clinical trials to manufacturing and pharmacovigilance, AI is transforming how medicines are developed, assessed, and monitored. The European Medicines Agency (EMA) published its 2025 AI Observatory Report to provide an overview of AI-related activities across the European Medicines Regulatory Network (EMRN). The report highlights
Sharan Murugan
Jun 63 min read