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 ...

We spoke with five RAPS Convergence attendees to get their reactions on what made this event special, from a focus on artificial intelligence (AI) to finding community, and more.

The US Department of Health and Human Services (HHS) and the US Food and Drug Administration (FDA) are seeking public input on regulations, rules, or guidelines that should be eliminated under ...

The appointment, announced on Twitter Monday morning, comes after Cavazzoni spent the past year as acting director of CDER. A game of musical chairs within FDA has been created by securing the ...

The European Commission earlier this month issued an updated notice detailing how it handles duplicate marketing authorization applications (MAAs) for pharmaceuticals and biologics, three years after ...

A weekly update on new drug approvals and indications from the US Food and Drug Administration (FDA). Corium’s Azstarys (serdexmethylphenidate [SDX] and dexmethylphenidate [d-MPH] capsule) has been ...

In its first warning letter of the year, the US Food and Drug Administration@s (FDA) Office of Prescription Drug Promotion (OPDP) last week cited AcelRx Pharmaceuticals over promotional materials for ...

Janet Woodcock, the long-serving director of the US Food and Drug Administration@s (FDA) Center for Drug Evaluation and Research (CDER), is officially the agency@s acting commissioner and is ...

Documents related to COVID-19 vaccines that were unlawfully accessed in a cyberattack against the European Medicines Agency (EMA) and subsequently leaked online were intentionally manipulated, the ...

A newly finalized guidance from the US Food and Drug Administration (FDA) smooths the path for manufacturers of devices and device-led combination products that stand to improve the safety of existing ...

The European Medicines Agency (EMA) has refreshed its points to consider document on remote pharmacovigilance inspections during a crisis, such as the current COVID-19 pandemic.