Complete Response Letters

MediWound, Ltd.: “concentrate of proteolytic enzymes enriched

What FDA's Complete Response Letters to the company say, in the letters' own words.

EphemerisX Research · Sep 30, 2026 · Sources: FDA, SEC

Complete Response Letter, Jun 25, 2021

Provide additional data to fully characterize the clEF profile of the drug product and support the identity of each of the peak groups included in the release specification.

Complete Response Letter · Jun 25, 2021 · p. 8Open the letter at p. 8 ↗CRL_BLA761192_20210625:p4:s18

November 14, 2019 and FDA's IR dated December 19, 2020, quality control starts with the BRM.

Complete Response Letter · Jun 25, 2021 · p. 13Open the letter at p. 13 ↗CRL_BLA761192_20210625:p7:s2

More Complete Response Letters

All companies in the CRL Tracker →

Updated Sep 30, 2026 · built from 283 companies in the EphemerisX knowledge graph. This page is regenerated as companies are added.