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Combination Products Regulation at the FDA
Author(s) -
Lauritsen KJ,
Nguyen T
Publication year - 2009
Publication title -
clinical pharmacology and therapeutics
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.941
H-Index - 188
eISSN - 1532-6535
pISSN - 0009-9236
DOI - 10.1038/clpt.2009.28
Subject(s) - food and drug administration , clinical pharmacology , medicine , drug , pharmacology , drug approval , investigational drugs , intensive care medicine , public health , business , medical physics , clinical trial , nursing
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. Clinical Pharmacology & Therapeutics (2009); 85 , 5, 468–470 doi: 10.1038/clpt.2009.28