CHEMBIOMED, LTD., Opportunity for a Hearing on a Proposal To Revoke U.S. License No. 0916

摘要

The Food and Drug Administration (FDA) is announcing an opportunity for a hearing on a proposal to revoke the biologics license (U.S. License No. 0916) issued to CHEMBIOMED, LTD. (CHEMBIOMED), for the manufacture of Anti-A (Murine Monoclonal), Anti-B (Murine Monoclonal), Anti-Le\a\ (Murine Monoclonal) and Anti-Le\b\ (Murine Monoclonal). The proposed revocation is based on information that the firm is no longer in operation and the manufacture of its licensed products has been discontinued.