It’s out with the old, in with the new at the FDA as the agency is unveiling a new adverse events monitoring system that joins several reporting systems into one unified platform, an effort that’s ...

In today's ACT Brief, we examine why eClinical platforms must prioritize user workflows over data flow, how digitizing sample tracking prevents integrity failures in transit, and the FDA's ...

FIRST ON FOX: The Food and Drug Administration (FDA) rolled out a new platform, backed by artificial intelligence, that will streamline publicly accessible reporting of negative or unexpected health ...

The FDA has launched a new adverse event reporting system that will consolidate several systems it has for reporting different types of adverse events, the agency announced Wednesday. The new system, ...

When safety concerns emerged for an FDA-regulated product, the suspected problem could be reported to one of seven online databases. The agency is now consolidating this reporting into a single online ...

The latest action fits with Makary’s promise to overhaul the FDA while speaking to a priority of Health and Human Services Secretary Robert F. Kennedy Jr., a vaccine skeptic who has long theorized ...