The Feinstein Institute for Medical Research: Fluorodopa F

Act for Fluorodopa F 18 Injection, 0.42 mCi/mL to 8.33 mCi/ml.

We acknowledge receipt of your major amendment dated April 11, 2016, which extended the goal date by three months.

We also acknowledge receipt of your amendment dated August 31, 2016, which was not reviewed for this action.

This study does not provide sufficient confirmatory evidence of effectiveness and the Fluorodopa F 18 PET scan's performance is not adequately characterized.

Out of these 13 patients, only 5 patients had undergone a clinical follow up which was to serve as a standard of reference and only 1 of these patients had a clinical follow up at a pre-defined time interval following the Fluorodopa F 18 PET scan (>1 year).

Fluorodopa F 18, only 1 patient had this interpretation adequately verified.

8. Provide English translations of current approved foreign labeling not previously submitted.

As per your amendment dated April 14, 2016, we remind you of your commitment to provide information regarding (4)

August 31, 2016, containing chemistry information to address this commitment.

As noted above, your August 31, 2016 amendment was not reviewed for this action and may be incorporated by specific reference if you decide to resubmit this application.