RECENT FACET SUCCESSES – JUST A FEW HIGHLIGHTS
FACET HELPS PHYSICIAN GET IND FULL HOLD LIFTED
Facet successfully prepares Complete Response (CR) to Investigator IND full hold to allow PI to proceed into the clinic. FDA placed an investigator-initiated IND on clinical hold, citing safety concerns. The investigator’s IND was designed to evaluate whether a commercially available product approved to treat a rare disease would be efficacious and safe in treating a common disease for which there is no cure. Facet prepared a thorough dose justification and proposed a comprehensive safety monitoring program to ensure safe use in the new patient population. FDA agreed to the modifications to the protocol and the study was allowed to proceed.
FACET HELPS GROWING ORGANIZATION SUBMIT SECOND IND
Facet prepares and submits IND to support growing portfolio. One year after Facet worked with a small company to help them prepare and submit their first IND, Facet helped the company add another NCE their growing pipeline of IND-enabled products. Over the course of several months, Facet and the company worked together to set the regulatory strategy for the novel product and develop consistent messaging in the IND components. Facet also helped the company successfully manage the very active open IND while simultaneously preparing the new IND for submission to FDA.
FACET STRATEGY PROVIDES FAST, AFFORDABLE PATHWAY FOR GAME CHANGING MEDICAL DEVICES
Facet lends medical device and CMC expertise to set 510(k) strategy for product platform. Facet was asked to help to advise on the most appropriate regulatory route for several related medical device products that were paired with chemical ingredients. Each product was a variation on a novel technology that, if cleared/approved, would revolutionize the wound care industry. Facet provided recommendations on the most likely regulatory pathway and outlined the approximate timelines, costs, and activities associated with product development from current state through to regulatory clearance/approval. In addition, Facet outlined the necessary steps for chemical testing and provided design elements of the work needed to ensure that CMC development would satisfy FDA requirements. Facet also recommended that this Sponsor engage FDA in Q-sub meetings and discuss whether this platform of products would be eligible for the Breakthrough Device program.