Posted by Michael Wonder on 20 Dec 2018
ADMA Biologics provides regulatory update on Bivigam PAS submissions
19 December 2018 - FDA issues complete response letter for drug substance, approves supplement for drug product.
ADMA Biologics announces that the U.S. FDA has issued a complete response letter (CRL) for the drug substance Prior Approval Supplement (PAS) submission and previously approved the drug product PAS submission.
The FDA approved ADMA’s drug product PAS submission which was comprised of fill, finish and final release information of the drug product. The FDA issued a CRL to ADMA pertaining to only the drug substance PAS submission which pertains to chemistry, manufacturing and controls information. In the CRL, the FDA did not request any information pertaining to compliance status, clinical study safety and efficacy nor any information requests regarding third party contract manufacturers and vendors.
