Cellular and Gene Therapy Products
Cellular therapy products include cellular immunotherapies, and other types of both autologous and allogeneic cells for certain therapeutic indications, including adult and embryonic stem cells.
Human gene therapy refers to products that introduce genetic material into a person's DNA to replace faulty or missing genetic material, thus treating a disease or abnormal medical condition.
The Center for Biologics Evaluation and Research (CBER) regulates cellular therapy products, human gene therapy products, and certain devices related to cell and gene therapy. CBER uses both the Public Health Service Act and the Federal Food Drug and Cosmetic Act as enabling statutes for oversight.
Featured Products
Best Practices in Quality and Compliance Management
Price: $70.00
Price: $70.00
FDA Expectations for Cell, Tissue and Gene Therapy Products
Unique properties of Cell and Gene Therapy Products - FDA Regulation - pre PRE IND process - Efficacy and proof of concept studies
Unique properties of Cell and Gene Therapy Products - FDA Regulation - pre PRE IND process - Efficacy and proof of concept studies
Delivering Biopharmaceutical Facilities in a Risk Based World: The Role of GEP, QbD, and E2500
Applicable regulatory guidelines - manufacturing of Biopharmaceutical APIs - GMP requirements - cell culture/fermentation - cell bank maintenance and recordkeeping
Applicable regulatory guidelines - manufacturing of Biopharmaceutical APIs - GMP requirements - cell culture/fermentation - cell bank maintenance and recordkeeping
Making Sense of FDA's (proposed) Rules for the Development and Approval of Biosimilars
Marketing and sale of biosimilars - FDA guidance documents - Reference Biological Product - Clinical Data - biosimilar approval
Marketing and sale of biosimilars - FDA guidance documents - Reference Biological Product - Clinical Data - biosimilar approval
