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Wright Medical Group, Inc.
today announced it has reached an
agreement with the Office of Device Evaluation (ODE) of the U.S. Food and Drug
Administration (FDA) under which ODE will accept a further amendment to the
Pre-Market Approval application (PMA) for Augment^® Bone Graft in lieu of
proceeding with the Dispute Resolution Panel (DRP) that was scheduled for the
week of May 19, 2014. The agreement with ODE remains subject to final approval
by the FDA appeal authority. That approval is expected shortly.
The PMA amendment, which the company expects to submit on or about March 31,
2014, will consist of analyses of pre-existing radiographic films of clinical
study patients at pre-operative and post-operative time points. ODE has
committed to an expeditious review of the PMA amendment and agreed to issue a
determination on whether the PMA is approvable no later than 180 days after
submission of the PMA amendment. The company intends to renew the DRP process
if the PMA amendment fails to result in a reversal of ODE's previous not
approvability determination.
Commenting on this development, Robert Palmisano, president and chief
executive officer, stated, “Since inception of the DRP process, Wright and ODE
were encouraged by the FDA Ombudsman to continue discussing alternative ways
to resolve the dispute. These discussions proceeded slowly but gathered steam
in recent days as the timeline for DRP submissions grew nearer. The result is
something we consider to be a good mechanism for moving forward.”
Palmisano continued, “While this development is cause for somewhat greater
optimism than we have thus far had reason to embrace, it is important to
reiterate that the parties' positions are still far apart and there is no
guarantee this PMA amendment will result in an approval for Augment Bone
Graft. Nevertheless, we are pleased we were able to work collaboratively with
FDA to identify a path forward that does not require new clinical studies to
get to the next approvability determination.”
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