The Pre-Competitive Consortium for OA (PCCOA) was created by OARSI more than a decade ago in response to a Federal Register Notice seeking a critical appraisal on a number of questions that would help to inform the updating of the 1999 guidance for Clinical Development Programs for the Treatment and Prevention OA. Subsequently in 2016, OARSI submitted a White Paper to the FDA providing a comprehensive review and rationale for OA to be defined as a potentially serious disease and to demonstrate that evidence from numerous data analyses provided justification for consideration of the use of surrogate markers in studies of some patients with OA for the early approval of structure modifying drugs. In October of 2018, OARSI responded to another Federal Register Notice seeking comment on a draft guidance for Structural Endpoints for the Development of Products for the Treatment of OA.
With the totality of this work undertaken by OARSI, a public meeting will take place on May 16, 2019 in Washington, DC to allow for an open dialog among all meeting participants on the issues surrounding the development of therapies that treat structural progression of OA and the continued unmet medical need for new therapies being available to patients diagnosed with OA.
The meeting will take place at the Marriott Georgetown Hotel, 1221 22nd St. NW, Washington, DC.
Click here to see the agenda
Register here for this free meeting. RSVP BY MAY 9
Background reading - Previous Submissions to FDA Federal Register Notices