FDA publishes a guidance to help in assessing the credibility of computational modeling and simulation in medical device submissions.
An Iqvia Institute report says drug shortages continue to increase in the U.S., with the number of new shortages outpacing the number resolved.
FDA commissioner Robert Califf calls on the Healthcare Distribution Alliance to give aggregate information to the agency on the distribution of Covid ...
The central Utah federal court approves two consent decrees of permanent injunction against Evig LLC and Premium Production LLC over their distributio...
After releasing promising clinical data, SpringWorks Therapeutics says it will file an NDA in the first half of 2024 for mirdametinib, an investigatio...
FDA principal deputy commissioner Janet Woodcock announces she is retiring early next year after 37 years at the agency.
An FDA-funded report makes recommendations for improving the cybersecurity of legacy medical devices.
FDA approves a Bristol Myers Squibb NDA for Augtyro (repotrectinib) for treating adult patients with locally advanced or metastatic ROS1-positive non-...
