The Combination Products Coalition says its members have several concerns with recent FDA requests for validation of product interface specifications.
Federal Register notice: FDA determines for patent extension purposes the regulatory review period for Kyowa Kirins Nourianz (istradefylline).
Two Wiley Rein attorneys caution medical device manufacturers to start preparing their transition plans and marketing applications for devices that we...
FDA appears to be raising the bar for sponsors seeking accelerated approval by requesting that they be well underway with their Phase 3 confirmatory t...
FDA approves Regeneron Pharmaceuticals PD-1 inhibitor Libtayo (cemiplimab-rwlc) in combination with platinum-based chemotherapy for the first-line tre...
Office of Combination Products director Thinh Nguyen says seven draft and final guidances affecting combination products should be published in the fi...
Federal Register notice: FDA makes available a final guidance entitled Studying Multiple Versions of a Cellular or Gene Therapy Product in an Early-Ph...
Federal Register notice: FDA posts a final guidance entitled M10 Bioanalytical Method Validation and Study Sample Analysis.
