7: The Regulation of Biologics
- Page ID
- 39518
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Objectives
- Define biologic
- Outline the approval process for biologics
- Distinguish the different product categories CBER has regulatory authority
- Differentiate between a drug, biologic, generic drug, reference product, and biosimilar
- 7.1: Introduction to Biologics
- Biologics are revolutionizing the biotechnology and health sector – and the most important biotechnology products of this century. Biologics include vaccines, tissue transplants, gene therapy, & stem cell treatment and may include biological molecules such as proteins, and nucleic acids, living tissues, and cells. Some biologics treat a disease or disorder, and some diagnose or prevent them.
- 7.2: The Center for Biologics, Evaluation, and Research
- The Center for Biologics, Evaluation & Research (CBER) is the primary Center in the FDA, which oversees the regulation of biologic & related products. We will explore in this chapter the broad range of biological products CBER reviews. There are three main review offices in CBER; Office of Blood Research and Review (OBRR); Office of Cellular, Tissue and Gene Therapies (OCTGT); and the Office of Vaccine Research and Review (OVRR).
- 7.3: Processes for Drug Approval
- The FDA regulates clinical studies in the US, and unapproved drugs and biologics must be conducted under an Investigational New Drug Application (IND). The IND is continually updated with new protocols, study data, and annual reports. The IND for a biologic must contain administrative information, preclinical research results, any previous human experience with the drug, and the clinical protocol. The IND is never approved; rather, it is pending, active, on hold, or partial hold.
- 7.5: Labeling
- Labeling here is referring to the display of written or printed material on the container or an enclosed document. Labeling includes both FDA approved labelings such as container labels, professional labeling in the package insert (PI – prescribing information), patient labeling (PPI – patient package inserts), medication guides, and instructions for use. But also, any promotional material.