NRX Pharmaceuticals Inc (NRXP)

[Bob1968]

NRX received the FDA QUIDP for the NRX-101 in Complicated Urinary Tract Infection and Pyelonephritis

From the FDA: III. QIDP DESIGNATION DEFINED



47
48 Section 505E(g) of the FD&C Act provides for the designation by FDA of certain
49 antimicrobial products as QIDPs. A QIDP is defined in section 505E(g) as: "an
50 antibacterial or antifungal drug for human use intended to treat serious or life-threatening
51 infections, including those caused by –
52
53 (1) an antibacterial or antifungal resistant pathogen, including novel or emerging
54 infectious pathogens; or
55
56 (2) qualifying pathogens listed by the Secretary under" section 505E(f) of the
57 FD&C Act.
58
59 The Agency has codified the list of qualifying pathogens at 21 CFR 317.2.
60
61 For a drug product to be designated a QIDP, the sponsor is required to demonstrate that the drug
62 is an "antibacterial or antifungal drug for human use intended to treat serious or life-threatening
infections."3 63 A sponsor requesting a QIDP designation may also include documentation that the
64 product is intended to treat an "antibacterial or antifungal resistant pathogen, including novel or
emerging infectious pathogens"4 65 or a qualifying pathogen as part of the designation request;
66 however, such documentation is not required.