Center for Biologic's OCBQ found a brochure for Panhematin (hemin for injection) to be misleading because it failed to include sufficient product risk information. According to the FDA-approved PI, Panhematin is an enzyme-inhibitor derived from processed red b...

9172W Abbott Labs, Abbott Park, IL, July 6 (CBER-Office of Regional Operations). The letter stated that Abbott failed to establish a hold time for hemin between processing and the start of lyophilization for Panhematin and that the firm had not completed vali...