Become a speaker or poster presenter in Lisbon The Euro Convergence Programme Committee invites you to propose a preconference workshop, concurrent session, solutions circle, or poster presentation ...

RAPS has named four regulatory professionals to the distinguished ranks of the RAPS Fellows Program. RAPS welcomes a new class of Fellows each year, honoring them for their noteworthy and sustained ...

The top official at the US Food and Drug Administration’s (FDA) drug center is retiring after almost a decade at the agency. On 23 June, Jacqueline Corrigan-Curay, acting director of the Center for ...

The practice of a brand manufacturer delaying the launch of an authorized generic medication has declined over recent years, and its effects on the market can be both positive and negative depending ...

Welcome to Regulatory Reconnaissance, your regulatory news and intelligence briefing. In Focus: US Senators Propose Ban on Drug Advertising to Consumers (The Wall Street Journal) Sarepta reports ...

This session will highlight the unique characteristics of software and offer practical tips for addressing its risks in a way that meets regulatory expectations.

Join experts as they demystify EUDAMED’s UDI requirements and offer actionable insights to help MedTech enterprises craft a comprehensive UDI strategy to drive compliance to EUDAMED and future UDI ...

This event will share an update to the AI landscape, including challenges to AI development, standards & regulations to address these challenges, and a deeper dive into AI risk and AI cybersecurity.

The RAPS Marketplace will be under maintenance on 26 June 10 PM to 11 PM ET. RAPS Marketplace may be unavailable during this window. We apologize for any inconvenience caused during this time.

The UK Medicines and Healthcare products Regulatory Agency (MHRA) has laid the groundwork for the implementation of new clinical trial regulations in April 2026 by publishing a series of guidelines.

The International Council for Harmonisation (ICH) has released its highly anticipated draft guideline that harmonizes principles for the design, analysis, and reporting of adaptive clinical trials in ...

Welcome to another installment of This Week at FDA, your weekly source for updates@big and small@on FDA, drug, and medical device regulation and what we@re reading from around the web. This week, FDA ...