Sep 26, 2017 | Medical Devices, White Paper
The White Paper provides real-world and practical information directed to the manufacturer of Class II and Class III devices in navigating the Premarket Notification 510(k) clearance with insight into the various documentation required by FDA for submitting a 501(k)…
Sep 1, 2017 | Foods, FSMA Perspective
FDA released two useful tools last month to advise and assist companies in complying with new FSMA rules. The agency issued a Small Entity Compliance Guide(SECG) to help small food businesses comply with the FSMA final rule on Mitigation Strategies to Protect Food...
Sep 1, 2017 | Issue of the Month
By Tara Lin Couch, Ph.D., EAS Senior Director, Dietary Supplements and Tobacco Contract laboratories provide an extremely valuable and necessary service to the dietary supplement industry. The own-label distributor or manufacturer rarely has an in-house laboratory...