process validation for expedited approval drugs

White Paper:

Cell Therapies Come of Age: Overcoming Challenges Within the Regulatory Framework

Within the cell therapy arena, regulators, the medical community and industry alike are often confronted with an unsettling question. What is this, really?

Should a given cell therapy be regulated as human cells, tissues, and cellular and tissue-based products (HCT/Ps), or should the cell therapy be regulated as a drug with the FDA oversight and regulatory approval process that accompanies that designation?

As cell therapies have become more common and indications have expanded, it’s becoming increasingly common to be trapped in ‘no mans land’ trying to answer this question, creating tension and confusion for the range of stakeholders involved in the decision-making process. Today, the dispute primarily centers around somatic stem cells that are harvested and prepared for transplantation through minor surgical procedures at stem cell clinics and other medical service providers.

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