Interview Coach (Exclusive RAPS Member Benefit) Master the art of interviews with expert insights and strategies to make a lasting impression. Learn 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 ...

A weekly update on new drug approvals and indications from the US Food and Drug Administration (FDA). New approvals Verkazia okayed for treating vernal keratoconjunctivitis Santen’s Verkazia ...

The US Food and Drug Administration (FDA) is seeking comments on strategies for the pharmacological assessment of peptides, small polymers made up of 40 or fewer amino acids. “For the purpose of this ...

Patrizia Cavazzoni, MD, has been named director of the US Food and Drug Administration’s Center for Drug Evaluation and Research (FDA’s CDER). The appointment, announced on Twitter Monday morning, ...

In a Wednesday status update on the European Medicines Agency's (EMA's) ongoing investigation into rare reports of blood clotting problems in people who have received the AstraZeneca COVID-19 vaccine, ...

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 ...

In recent years, global clinical trials have become standard, and for a good reason. In broad terms, expanding clinical trials across the world provides a better opportunity for demonstrating the true ...

Woodcock’s tenure at FDA began at the Center for Biologics Evaluation and Research (CBER) in 1986, where she held various division and office director-level roles before being promoted to CDER ...

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 ...

Editor's note: This article has been updated to reflect clarification from HHS about who will fill the role of chief counsel. The US Food and Drug Administration’s (FDA) top lawyer, Chief Counsel ...

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 ...