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CHARLOTTE, NC — Officials from the US Food and Drug Administration (FDA), the European Medicines Agency (EMA), and industry representatives offered advice for considering and developing clinical trials that achieve representative enrollment of patient populations.

CHARLOTTE, NC — Experts in medical device and pharmaceutical regulatory affairs discussed how the field has evolved over the last five decades and how professionals can continue to face the challenges that come their way during the opening plenary session of RAPS Convergence 2026.

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

The US Food and Drug Administration (FDA) announced on Tuesday the launch of a pilot program designed to expedite the review of early-phase clinical trials for investigational new drugs (INDs). This program introduces a rolling submission process that pairs sponsors with qualified research institutions.

The US Food and Drug Administration (FDA) recently issued warning letters to ophthalmic product maker Bausch and Lomb and an Indian active pharmaceutical ingredient (API) maker for violations of good manufacturing practice (GMP). Both companies were cited for having lax contamination controls.