
LINKS
Mexico’s Comisión Federal para la Protección contra Riesgos Sanitarios (COFEPRIS)
Argentina’s Administración Nacional de Medicamentos Alimentos y Tecnología Médica (ANMAT)
Advancing Health Through Innovation: New Drug Therapy Approvals
FDA GUIDANCE & CODE OF FEDERAL REGULATIONS RELEVANT TO CGT INVESTIGATIONAL PRODUCTS
Human Gene Therapy Products Incorporating Human Genome Editing
Manufacturing Changes and Comparability for Human Cellular and Gene Therapy Products
Industry Potency Assurance for Cellular and Gene Therapy Products
Considerations for the Development of Drugs and Biological Products
Studying Multiple Versions of a Cellular or Gene Therapy Product in an Early-Phase Clinical Trial
Interpreting Sameness of Gene Therapy Products Under the Orphan Drug Regulations
Long Term Follow-Up After Administration of Human Gene Therapy Products
Considerations for the Design of Early-Phase Clinical Trials of Cellular and Gene Therapy Products
Preclinical Assessment of Investigational Cellular and Gene Therapy Products
A Regulatory Perspective on the Quality Overall Summary: Putting the Pieces Together
Content and Format of Investigational New Drug Applications (INDs) for Phase 1 Studies of Drugs
Human Cells, Tissues, and Cellular and Tissue-Based Products