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Like so many of us in regulatory affairs, my career has taken a few twists and turns to get to where I am now.

Each year, our society honors a new class of RAPS Fellows for their noteworthy and sustained leadership contributions to their organizations, to RAPS, and to the regulatory affairs profession. Each new Fellow will be honored at RAPS Convergence 2026 on 15-17 September in Charlotte, North Carolina.

The FDA’s Office of Prescription Drug Promotion recently reprimanded Sanofi and Viatris for making misleading claims about their products in emails and a television advertisement.

The European Commission's Medical Device Coordination Group (MDCG) says unique device identifiers and device identifiers (UDI-DI) codes used between manufacturers and distributors need to be better standardized as they are added to Europe's new clinical trial database the European Database on Medical Devices (Eudamed).

The European Commission on Monday published new guidelines to assist providers and deployers of artificial intelligence (AI) systems in fulfilling transparency obligations under the EU’s AI Act, including examples of exceptions to these requirements. While not specific to healthcare products, companies developing healthcare products with an AI system component may be subject to transparency rules.

The US Food and Drug Administration has issued warning letters to several drug makers for failing to meet its current good manufacturing practices (CGMP) requirements and a company for failing to sufficiently inform subjects about the clinical trial they were participating in.

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14 professionals have been recognized as the 2026 recipients of the RAPS Awards, which celebrate outstanding contributions to the regulatory affairs profession. Each recipient will be celebrated in person at RAPS Convergence 2026 on 15-17 September in Charlotte, North Carolina.

The UK's Medicines and Healthcare products Regulatory Agency (MHRA) touted its achievements over the last year its 2025-2026 annual report to Parliament, which includes approving more new drugs than the prior year, removing a record number of illegal drugs from circulation, and taking steps to advance the regulation of artificial intelligence (AI) in healthcare.

While China's National Medical Products Administration (NMPA) approved more oncology drugs compared to the US Food and Drug Administration (FDA) from 2020 to 2025, the US regulator approved more first-in-class drugs and tended to approved products faster and earlier than China, according to a recent study published in Health Affairs.