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The following are settlements reached with US authorities against pharmaceutical companies to resolve allegations of "off-label" promotion of drugs. Under the Federal Food, Drug, and Cosmetic Act, it is illegal for pharmaceutical companies to promote their products for uses not approved by the Food and Drug Administration (FDA), and corporations that market drugs for off-label indications may ...
The markets for kids and the elderly were called out as special priorities, Starr says, “because that’s where they saw all the growth. With adults, you pretty much have to focus on the actual diseases—like schizophrenia—because adults don’t end up at the doctor getting drugs for acting up. But kids, or the elderly with dementia, do.”
Off-label use is the use of pharmaceutical drugs for an unapproved indication or in an unapproved age group, dosage, or route of administration. [1] Both prescription drugs and over-the-counter drugs (OTCs) can be used in off-label ways, although most studies of off-label use focus on prescription drugs.
Landmark court decisions, in present-day common law legal systems, establish precedents that determine a significant new legal principle or concept, or otherwise substantially affect the interpretation of existing law. "Leading case" is commonly used in the United Kingdom and other Commonwealth jurisdictions instead of "landmark case", as used ...
Case law, also used interchangeably with common law, is a law that is based on precedents, that is the judicial decisions from previous cases, rather than law based on constitutions, statutes, or regulations. Case law uses the detailed facts of a legal case that have been resolved by courts or similar tribunals. These past decisions are called ...
In some cases, a prescription may be transmitted orally by telephone from the physician to the pharmacist. The content of a prescription includes the name and address of the prescribing provider and any other legal requirements, such as a registration number (e.g., a DEA number in the United States). Unique to each prescription is the name of ...
Schedule 1 drugs have little or no medical benefit, hence their limitations on prescribing. District nurses and health visitors have had limited prescribing rights since the mid-1990s; until then, prescriptions for dressings and simple medicines had to be signed by a doctor. Once issued, a prescription is taken by the patient to a pharmacy ...
The number of prescribers rose last year after doctors no longer needed to get a special waiver to prescribe the drug, while the number of patients filling prescriptions barely budged.