Individuals may self-nominate or be nominated by any person or organization.Read More
Tags : U.S. Food and Drug Administration
The materials would show whether the FDA balanced the health benefits and risks.Read More
An industry insider detects “a clear escalation” as the agency moves beyond warnings.Read More
Neil McKeganey explains how companies can make the most of a recent ruling forcing the FDA to reconsider MDOs. Read More
AVM says its members alone have received more acceptance letters than the FDA admits. Read More
The FDA’s approach was both reasoned and consistent with the law, according to ruling. Read More
A court ruling requires the agency to take a another look at six marketing applications.Read More
The update requires no additional action by firms with pending determination request.Read More
The manufacturer has failed to submit a PMTA, according to the agency. Read More
Despite onerous requirements on applicants, the agency was happy to cut its own paperwork.Read More
