Combination products regulation at the FDA.
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.
Lauritsen
K J
KJ
Office of Combination Products, US Food and Drug Administration, Rockville, Maryland, USA. kristina.lauritsen@fda.hhs.gov
Nguyen
T
T
D001688:Biological Products / Q000009:adverse effects / Q000592:standards; D018795:Device Approval / Q000331:legislation & jurisprudence*; D017277:Drug Approval / Q000331:legislation & jurisprudence* / Q000458:organization & administration; D064420:Drug-Related Side Effects and Adverse Reactions; D004864:Equipment and Supplies / Q000009:adverse effects / Q000592:standards; D006801:Humans; D004364:Pharmaceutical Preparations / Q000592:standards; D014481:United States; D014486:United States Food and Drug Administration / Q000331:legislation & jurisprudence / Q000458:organization & administration*
D001688:Biological Products; D004364:Pharmaceutical Preparations