Complete Response Letters
Phathom Pharmaceuticals, Inc.: Voquezna
What FDA's Complete Response Letters to the company say, in the letters' own words.
Complete Response Letter, Feb 7, 2023
The methods to be used in, and the facilities and controls used for, the manufacture, processing, packing, or holding of the drug substance or the drug product are inadequate to preserve its identity, strength, quality, purity, stability, and bioavailability (21 CFR 314.125(b)(1)).
CRL_NDA215151_20230207:p1:s15More Complete Response Letters
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