RECENT FACET SUCCESSES – JUST A FEW HIGHLIGHTS

FACET HELPS SMALL ORGANIZATION HOLD SUCCESSFUL FDA MEETING
Small organization reaches FDA agreement on BLA requirements for novel diagnostic in Type C meeting.  Facet often works with organizations developing novel and innovative products that have no regulatory precedent.  When this occurs, it is necessary to have frequent communications with FDA to ensure the most rapid and cost-effective development possible.  Facet worked with a small company struggling to come to agreement with FDA on the required efficacy and safety data needed for a regulatory approval of their novel biological diagnostic imaging agent.  Facet provided overarching strategic guidance and helped the company prepare for the FDA meeting.  As part of the meeting, there was an extensive discussion of the Sponsor’s planned pivotal studies, desired indication, and use of supporting data from the literature.  Several agreements were achieved, and the Sponsor received important, actionable information about FDA’s position on the required safety database, safety monitoring, and possible indications for the product.

FACET HELPS SECURE RELEASE FROM POSTMARKETING REQUIREMENTS
Facet sets the strategy and drafts a successful argument for PMR release. A very large ex-US company received FDA approval several years ago for a novel pediatric product for an unmet medical need.  The approval letter outlined several pharmacokinetic postmarketing study requirements (PMRs).  For a variety of reasons, the product remained unmarketed for several years.  The company recently divested the product to a small ex-US company that wanted to bring the product to patients in need.  Facet and the company prepared a sound and scientific justification that was partially based around the ethical concerns of PK testing in children FDA guidance, Ethical Considerations for Clinical Investigations of Medical Products Involving Children (September 2022) supporting the release of the postmarketing requirements.  After FDA’s review, all PMRs were lifted and the company is now preparing for commercial launch.