News & Insights Search

RAPS Convergence is where the world’s regulatory affairs community gathers to share expert insights and create meaningful connections. We’re talking to the speakers behind this year’s event to get the inside scoop on the topics everyone will be talking about and their tips for making the most of your week. Next up: Marina Daineko, senior manager, compliance assurance at EPAM Systems. 

Documentation failures create an evidence problem, but their larger effect is risk and uncertainty.

The US Food and Drug Administration (FDA) on Wednesday finalized guidance addressing frequently asked questions related to the development of cellular and gene therapy (CGT) products.

Using the US Food and Drug Administration’s (FDA) plausible mechanism framework to allow for greater use of causal inference may help with evidence generation for rare diseases, according to a recent paper published in The Journal of Clinical Investigation.

The European Medicines Agency (EMA) is holding a consultation about a draft framework intended to cut the time it takes to implement data standards.

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

President Donald Trump has named White House aide Heidi Overton to lead the US Food and Drug Administration (FDA). Overton will fill the position previously held by Marty Makary, who left the agency in May. This announcement was made on Trump's Truth Social account on 19 August. Her nomination is subject to confirmation by the Senate.

We spoke with the Regulatory Intelligence Conference Europe Planning Committee to get their thoughts on the evolution of regulatory intelligence, their role in organisations, and what they are looking forward to at this year’s event.

The US Food and Drug Administration (FDA) has updated its seven-year-old guidance to clarify the differences among abbreviated approval pathways and the data it will accept for these applications. These pathways include the traditional Abbreviated New Drug Application (ANDA) process under section 505(j) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) and the 505(b)(2) pathway.

While there have been growing concerns in recent years about whether FDA decision-making might be influenced by external factors, research suggests measuring such influence is a complex task.