Regulatory Focus

Acting US Food and Drug Administration (FDA) Commissioner Kyle Diamantas said there is significant public interest in its recently announced Expedited Investigational New Drug (IND) pilot at the Friends of Cancer Research (FOCR) annual meeting on Tuesday.

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

BARCELONA – A panel of experts said that while technologies such as artificial intelligence (AI) can help aggregate and process vast amounts of regulatory information, regulatory professionals and human relationships are still needed to translate intelligence signals.

The US Food and Drug Administration (FDA) on Monday finalized guidance to assist manufacturers in validating in vitro diagnostic devices (IVDs) that test for emerging pathogens during public health emergencies. The guidance also provides recommendations on how this validation data should be submitted in a pre-Emergency Use Authorization (EUA) or an EUA request.

The Indian government has proposed immediately suspending the license of any company that produces a drug that is not of standard quality.

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

BARCELONA – As more regulatory professionals adopt artificial intelligence (AI) tools as part of their jobs, a panel of experts who spoke at the RAPS AI in Regulatory Conference advised attendees to take a risk-based, life-cycle approach. They also have detailed considerations for validating those tools and going further to ensure they can catch potential issues.

Welcome to another installment of This Week at FDA, your weekly source for updates – big and small – on FDA, drug and medical device regulation, and what we’re reading from around the web. This week, we’re looking at some of the ways the midterm election results could impact FDA over the next two years, starting with the confirmation prospects for President Trump’s pick for FDA commissioner and how Democrats may use their newfound oversight powers.