09.05.18
ADMA Biologics, a commercial biopharmaceutical company that manufactures, markets and develops specialty plasma-based biologics for the prevention and treatment of certain infectious diseases , said that the FDA inspection database classification website has been updated and confirms ADMA's compliance status has improved to Voluntary Action Indicated (VAI).
"We are pleased that the FDA has acknowledged the improved current good manufacturing practice ( cGMP ) conditions at our manufacturing facility and updated its database accordingly," said Adam Grossman, president and chief executive officer, ADMA Biologics. "We are excited to finally be in a position to resubmit our Biologics License Application ( BLA ) for RI-002 during the third quarter of 2018, which we believe is a needed Intravenous Immune Globulin (IVIG) option for patients who suffer with Primary Humoral Immunodeficiency Disease (PIDD). We will announce related information pertaining to RI-002's BLA filing when the company receives correspondence from FDA."
"We are pleased that the FDA has acknowledged the improved current good manufacturing practice ( cGMP ) conditions at our manufacturing facility and updated its database accordingly," said Adam Grossman, president and chief executive officer, ADMA Biologics. "We are excited to finally be in a position to resubmit our Biologics License Application ( BLA ) for RI-002 during the third quarter of 2018, which we believe is a needed Intravenous Immune Globulin (IVIG) option for patients who suffer with Primary Humoral Immunodeficiency Disease (PIDD). We will announce related information pertaining to RI-002's BLA filing when the company receives correspondence from FDA."
