licensed biological product / biological products / certain licensed biological products / manufacturing controls / drug product / unlicensed biological product / biological systems / manufacturing practices / allergenic product / biological product / hospital-based transfusion services / manufacturing protocols / manufacturing process / manufacturing use / human drugs products / gene therapy products / analogous product / manufacturing controls data / oral dosage form biological products / manufacturing steps / quality systems / container-closure systems / cell therapy products / manufacturing / certain biological products / drug products / manufactured using biological systems / /
MedicalCondition
serious patient injury / disease / /
MedicalTreatment
gene therapy / cell therapy / dialysis / /
Organization
U.S. Department of Health and Human Services / office of Communication / Outreach / and Development / Food and Drug Administration Center for Drug Evaluation and Research / Food and Drug Administration / office of Regulatory Affairs / office of Communications / U.S. Department of Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research / Medicare / Division of Dockets Management / D. Hospital / office of Communication / Outreach / and Development Center for Biologics Evaluation / Center for Biologics Evaluation and Research / Center for Biologics Evaluation and Research Food and Drug Administration / Drug Information Center for Drug Evaluation / /
Person
Cosmetic Act / Leah Christl / / /
Position
licensed pharmacist / General / Secretary / A. General / Governor / /
Mixing , Diluting, or Repackaging Biological Products Outside the Scope of An Approved Biologics License Application