FDA Requests Analyses, Inspection Fixes in CRL to Advanced Accelerator Applications for Tumor Therapy

December 29, 2016

The FDA has rejected Advanced Accelerator Applications’ candidate for the treatment neuroendocrine tumors in adults, requesting that the company submit new analyses and correct manufacturing deficiencies.

In a complete response letter, the agency asked Advanced Accelerator Applications to submit subgroup analyses for gender, age and race in addition to other stratification factors and disease characteristic analyses. The company must also resolve observations from FDA inspections of the manufacturing facilities supporting the NDA and provide a safety update on clinical and non-clinical studies. No additional clinical trials were requested.

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