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Prescribing information

Detailed instructions, dosage guidelines, safety warnings, and other critical data about a medicine, approved by the FDA, primarily for use by doctors and pharmacists.

Biological products

Medicines derived from living organisms, such as vaccines, blood components, gene therapies, and certain proteins.

Federal Food, Drug, and Cosmetic Act

The foundational U.S. law that grants the Food and Drug Administration (FDA) authority to regulate the safety and efficacy of food, drugs, cosmetics, and medical devices.

Prescriber

A healthcare professional, like a doctor or nurse practitioner, who is legally authorized to write prescriptions for medicines.

Dispenser

A healthcare professional, typically a pharmacist, who prepares and provides prescribed medications to patients.

Labeling

All written, printed, or graphic material that is either on a drug's container or accompanies the drug product, including the prescribing information.