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Foreign Regulatory Seminar (Web-Based) - Office of Tissues and Advanced Therapies

Overview: Office of Tissues and Advanced Therapies (OTAT)

Overview of the Office of Tissues and Advanced Therapies, discussion of each regulated product type, outreach, sponsor interaction, and laboratory research.

FDA Regulation of Human Cells and Tissues

Detailed discussion of the regulation of human cells and tissues, which includes product definitions, requirements for regulation, establishments, donor eligibility, and manufacturer responsibilities.

Cellular Therapy Products

Detailed discussion on the regulation of cellular therapies, which includes criteria for regulation, unique product challenges, testing methods, potency assays, and product characterization.

Manufacturing of Gene Therapies: Ensuring Product Safety and Quality

Detailed discussion on the regulation of gene therapy products and manufacturing, including other replicating products, to ensure product safety and quality.

Combination Product Review Issues

Review of biologic combination products, with specific examples of cellular therapy-device combination product scenarios.

Preclinical Considerations in Cell and Gene Therapy Product Development

Detailed pharmacology/toxicology discussion on the preclinical considerations when evaluating and developing cell and gene therapy products, and principles of regulatory review.

Clinical Study Issues in Early Phase Trials of Cell and Gene Therapies

Detailed discussion on the regulations related to early phase clinical trials of cell and gene therapies, including risks, protocol design, analysis, and donor issues.

Nonclinical Studies for Plasma Derived and Analogous Products

This presentation covers the approach to the review of nonclinical/preclinical toxicology studies for those products regulated by the Division of Plasma Protein Therapeutics (DPPT), in CBER’s Office of Tissues and Advanced Therapies (OTAT).

Viral Safety of Plasma-Derived Products

Discussion on viral validation studies for plasma-derived products, including viral safety, viral validation and viral clearance.

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