Complete response letter to the applicant
| Currency | Current through May 31, 2023 |
| Citation | 21 C.F.R. §314.110 |
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Gillis v. QRX Pharma Ltd.
- United States
- U.S. District Court — Southern District of New York
- July 6, 2016
...("CRL") that describes the deficiencies in the application and, where possible, provides recommendations for achieving approval. See Id. § 314.110.2. QRX's Early Communications with the FDAIn January 2004, QRX met with the FDA in anticipation of filing an Investigational New Drug ("IND") ap......