The U.S. Food and Drug Administration (FDA) has issued a Complete Response Letter (CRL) in response to Acer Therapeutics’ (NASDAQ:ACER) New Drug Application (NDA) for ACER-001 (sodium phenylbutyrate) for oral suspension in the treatment of patients with urea cycle disorders (UCDs).
The regulatory agency indicated in the CRL that its field investigator could not complete inspection of Acer's third-party contract packaging manufacturer, because the facility was not ready for inspection.
