FDA CRL - Thomas Chaly

The Food and Drug Administration (FDA) issued a Complete Response Letter (CRL) to The Feinstein Institute for Medical Research for their New Drug Application (NDA 200655) for Fluorodopa F 18 Injection, submitted under section 505(b)(2) of the Federal Food, Drug, and Cosmetic Act. The application was not approved due to significant clinical and Good Clinical Practice (GCP) deficiencies.

Major clinical issues included the absence of adequate and well-controlled trials, with submitted data deemed insufficient to evaluate the diagnostic effectiveness of Fluorodopa F 18 PET. Studies supporting the application (e.g., #15, #16, #21) were criticized for retrospective design, lack of pre-specified protocols, inadequate diagnostic reference standards, insufficient patient follow-up, and absence of independent, blinded image interpretation documentation.

A GCP inspection, with findings communicated on March 22, 2013, revealed critical deficiencies at the clinical site, including the lack of prospective study protocols, case report forms, and essential study records, which raised concerns about the reliability and integrity of the clinical data.

The FDA requires the company to conduct a new, adequate, and well-controlled clinical trial in compliance with GCP standards. This trial must include a pre-defined diagnostic reference standard, a pre-specified statistical analysis plan, and independent, blinded image interpretations, utilizing an appropriate patient population to effectively demonstrate the drug's efficacy.