FDA issues a training video to acquaint mammography facilities with inspection questions relating to image quality.
A National Law Journal online post explains four key points in an FDA draft guidance on biosimilar interchangeability.
FDA approves two Upsher-Smith Laboratories supplemental NDAs for Qudexy XR (topiramate) Extended-Release Capsules for use in preventing migraine heada...
FDA clears a RenovoRx 510(k) for its RenovoCath adjustable dual-balloon infusion catheter to include delivery of chemotherapeutics.
FDA emphasizes the importance of pre-submission meetings for developers and sponsors of neurological devices pursuing a de novo pathway to classify no...
A group of Senate Democrats introduce the Improving Access to Affordable Prescription Drugs Act that is intended to ensure drug companies put patients...
PhRMA asks FDA to suspend its implementation of a revised draft guidance on submitting quality metrics to allow for further dialog between industry an...
CDRH releases information on its 2016 accomplishments toward three strategic priorities.