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In medical device biocompatibility, gross observation is the starting point — not the finish line. If your implantation study report for a 510(k) simply says “no visible tissue reaction”, you’re setting yourself up for FDA pushback. Why? Because regulators know what seasoned toxicologists know: devices can cause microscopic and functional changes long before they cause visible tissue damage.

Choosing the wrong tissue site in an implantation study is one of the fastest ways to derail your 510(k) submission. We’ve seen FDA request repeat testing—adding months and tens of thousands of dollars—simply because the chosen implantation site didn’t match the device’s intended clinical use.

Most workplace biosafety programs fail for the same 3 reasons— and each one can expose your organization to unnecessary risk.

The National Institutes of Health (NIH) Therapeutics for Rare and Neglected Diseases (TRND) program is part of a congressionally funded effort to encourage and speed the development of new drugs for rare and neglected diseases. The federal budget for fiscal 2009 dedicated $24 million to establish this initiative. TRND will bridge the wide gap in time and resources that often exists between basic research and human testing of new drugs. The effort is grounded in, but aims to improve upon, existing processes for drug development in the pharmaceutical industry.