Regulatory Focus

Officials from the US Food and Drug Administration (FDA) reaffirmed the administration's priorities in the proposed commitment letter for the Prescription Drug User Fee Act (PDUFA VIII) program during a public meeting on Wednesday.

CHARLOTTE, NC — Officials from the European Commission and European Medicines Agency (EMA) touted key reforms presented in the proposal to overhaul the bloc’s pharmaceutical legislative framework during a panel discussion at RAPS Convergence 2026.

CHARLOTTE, NC — When former US Food and Drug Administration (FDA) Commissioner Robert Califf was a medical student in the mid-1970s, he had an opportunity to work with his mentor on one of the first patient databases. Patients undergoing cardiovascular procedures would have their data captured as a part of clinical care and were followed for life.

A commission set up by the Medicines and Healthcare products Regulatory Agency (MHRA) has shared 44 recommendations about the future regulatory framework for AI in the UK.

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CHARLOTTE, NC — A panel of experts representing the European Commission, industry, and notified bodies reviewed the state discussed the current state of play amid proposed reforms to the EU Medical Device Regulation (MDR) and In Vitro Diagnostics Regulation (IVDR) at RAPS Convergence 2026.

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.