FOLLOWING US FOOD and Drug Administra-tion (FDA) approval, clinicians may lawfully
prescribe a drug or biologic agent for treatment regimens not specified in the approved …

Yelling “Fire!” in a crowded theaterwithout any imminent danger is an oft-cited example of
free speech that is not protected. For many years, the US Food and Drug Administration …

Background Unlike medicines prescribed for Food and Drug Administration–approved
indications, off-label uses may lack rigorous scientific scrutiny. Despite concerns about …

Off-label prescribing may lead to innovative new uses of old medications, is essential in
such fields as pediatrics, and avoids the lengthy and expensive process of modifying US …

OFF-LABEL DRUG USE HAS BEEN around for decades, and it is perfectly legal for
physicians to prescribe a medication for a condition not described in the approved labeling if …

Background Off-label prescribing may lead to adverse drug events. Little is known about its
prevalence and determinants resulting from challenges in documenting treatment indication …

Off-label prescribing is an integral part of contemporary medicine. Many patients benefit
when they receive drugs or devices under circumstances not specified on the label …

The practice of promoting" off-label" use by pharmaceutical manufacturers is defined as the
promotion and marketing of pharmaceutical indications that have not been approved by the …

Today's medicines are regulated for their efficacy and safety and, once approved, they can
be marketed for certain uses as justified by the data. Regulatory bodies in developed …

Off-label prescribing occurs when a practitioner prescribes a drug for a use, or in a manner,
not authorized by the Food and Drug Administration (FDA). 1 When a drug is approved by …