Regulatory Focus

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.

RAPS Convergence 2026 is an opportunity for regulatory professionals to reflect on the evolution of the profession, look ahead to the changes brought on by new technologies, and redouble their focus on the end goal of delivering safe and effective products to patients.

The European Medicines Agency (EMA) has published a guideline on evaluating drug interactions in the gastrointestinal tract that addresses situations in which extrinsic factors in the gastrointestinal tract may affect drug absorption.

A recent report from the European Medicines Agency (EMA) highlights that global regulators are strongly committed to sharing plans for good manufacturing practice (GMP) inspections of active pharmaceutical ingredient (API) suppliers yet have made only moderate progress toward sharing inspection reports in recent years. Joint inspections remain a challenging area, evidenced by a 50% decrease compared to the previous reporting period.