Complete Response Letters
Provention Bio, Inc.: PRV-031
What FDA's Complete Response Letters to the company say, in the letters' own words.
Complete Response Letter, Jul 2, 2021
May 27, June 7, and June 25 (eCTD #56), 2021, which were not reviewed for this action.
CRL_BLA761183_20210702:p1:s13(1) The results of the pharmacokinetic (PK) bridging study PRV-031-004' in healthy volunteers failed to show PK comparability between the PRV-031 product used in TN-102 and the planned commercial product.
CRL_BLA761183_20210702:p1:s18The protocol provided in your submission dated March 31, 2021, for requalification of the primary reference standard (PRS) is deficient.
CRL_BLA761183_20210702:p2:s6(6) During a recent inspection of the om (FEI: 19) manufacturing facility for this application, our field investigators conveyed deficiencies to the representative of the facility.
CRL_BLA761183_20210702:p2:s19Satisfactory resolution of these deficiencies is required before this application may be approved.
CRL_BLA761183_20210702:p2:s20(4) In your submission dated March 29, 2021, you provided data to demonstrate hat oxidation of IM" affects PRV-031 potency (Section 3.2.S.7.1, Table 19 and Figure 12).
CRL_BLA761183_20210702:p3:s34PRV-031 samples to demonstrate the stability-indicating capability of the assay.
CRL_BLA761183_20210702:p4:s3More Complete Response Letters
Updated Sep 30, 2026 · built from 283 companies in the EphemerisX knowledge graph. This page is regenerated as companies are added.