Related Experiment Video
Updated: Jun 23, 2026

Chimeric Antigen Receptor T Cell Manufacturing on an Automated Cell Processor
Published on: August 18, 2023
Combination products regulation at the FDA
1Office of Combination Products, US Food and Drug Administration, Rockville, Maryland, USA. kristina.lauritsen@fda.hhs.gov
Abstract:
The US Food and Drug Administration (FDA) is responsible for protecting the public health by assuring the safety, efficacy, and security of drugs, biological products, and medical devices. As single-entity products, drugs are generally regulated by the Center for Drug Evaluation and Research (CDER), devices by the Center for Devices and Radiological Health (CDRH), and biologics by the Center for Biologics Evaluation and Research (CBER). In recent years, technological advances have led to a blurring of the historical lines of separation between the centers.
Related Concept Videos
Drug Regulation
Drug Products: Biologics, Biosimilars and Interchangeables
FDA Approved Drugs: Changes to Approved Drugs
Impact of Pharmacokinetic–Pharmacodynamic Models: Regulatory Decisions
Drug Control Governance: Regulatory Bodies and Their Impact
Clinically Relevant Drug Product Specifications: Methods of Establishment

