Why does BGTD have a Lot Release Program?
Since biologic drugs are isolated from, or manufactured using, living organisms, they are inherently more variable than chemically synthesized drugs and require additional regulatory oversight. Biologic drugs are sensitive to changes in the starting materials and manufacturing, and therefore difficult to consistently produce and characterize. The Lot Release Program provides an additional check on biologic drugs to help assure their safety for human use. The program is risk-based; the degree of regulatory oversight corresponds to the level of risk associated with the drug.
Related Questions
- How are release decisions being made right now? Are youth completing the program (A4B4C4) or are they just released automatically when their minimum lengths of stay are complete?
- Why is there no release strategy determination when a program changes in background a purchasing document which corresponds to the classification of a release strategy ?
- Does an insureds enrollment in the program release the administrator from HIPAA issues, since claim information and reimbursement will be exchanged?
