Regulatory Focus

LISBON – Regulators will need to evolve as new technologies come to market, according to experts who spoke at the opening plenary session of RAPS Euro Convergence 2026. Major challenges include finding the right balance between safety and regulatory flexibility and determining an acceptable level of uncertainty.

The US Food and Drug Administration (FDA) has issued warning letters to several firms that have violated current good manufacturing practice (CGMP) requirements, and one firm that has failed to submit an approved application for premarket approval (PMA).

Welcome to Regulatory Reconnaissance, your regulatory news and intelligence briefing.

The US pharmaceutical industry expressed support for the US Food and Drug Administration’s (FDA) proposed framework for increasing access to treatments for ultra-rare diseases yet raised questions concerning various aspects of the program.

COLUMBUS, OH – The difference between an anomaly and a defect in product software can be confusing, but it is important to identify which is which to properly handle problems that crop up in product software, two panelists recently told attendees, at the 2026 MedCon conference, sponsored by the AFDO/RAPS Healthcare Products Collaborative.

Agencies in Malaysia and Thailand have implemented a regulatory reliance program for medical devices after a successful three-month pilot.

Welcome to Regulatory Reconnaissance, your regulatory news and intelligence briefing.

The healthcare product landscape in Europe is undergoing significant transformation—from multiple legislative overhauls to the rapid adoption of artificial intelligence (AI) and other boundary-pushing technologies. For regulatory professionals attending RAPS Euro Convergence 2026 in Lisbon, the meeting is an opportunity to lean into community to stay on top of the myriad changes coming their way.