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How Fda Evaluates Drug Approvals

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‘‘Black box’’ 101: How the Food and Drug Administration evaluates, communicates, and manages drug benefit/risk
Shirley Murphy, MD, and Rosemary Roberts, MD Silver Spring, Md

A prominently displayed boxed warning, the so-called ‘‘black box,’’ is added to the labeling of drugs or drug products by the Food and Drug Administration when serious adverse reactions or special problems occur, particularly those that may lead to death or serious injury. Healthcare providers are often not knowledgeable about the origin, meaning, and implications of these ‘‘black box’’ warnings. In this review, our goal is to provide insight into how the Food and Drug Administration evaluates, communicates, and manages drug benefit/risk. We discuss drug labeling, the emphasis on safety throughout the drug approval process, legislative initiatives for safe use of drugs in children, and postmarketing safety surveillance. In addition, we encourage health care providers to report drug reactions to the Food and Drug Administration’s MedWatch program. A discussion of new Food and Drug Administration initiatives to improve drug safety processes and methods to serve the public better are highlighted. (J Allergy Clin Immunol 2006;117:34-9.) Key words: Food and Drug Administration, adverse drug reactions, MedWatch, ‘‘black box’’ warning, drug labeling, drug benefit/risk, risk management, postmarketing surveillance, drug development

Abbreviations used AERS: Adverse Event Reporting System CDER: Center for Drug Evaluation and Research CFR: Code of Federal Regulations DSOB: Drug Safety Oversight Board FDA: US Food and Drug Administration IND: Investigational new drug PDR: Physicians Desk Reference NDA: New drug application

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