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Prescribing Information

Official document or 'label' approved by the FDA that provides detailed instructions and safety information about a drug, including its uses, dosages, side effects, and warnings, for healthcare professionals.

Biological Products

Medicines derived from living organisms, such as vaccines, blood components, gene therapies, and tissue products, regulated similarly to drugs.

Federal Food, Drug, and Cosmetic Act (FFDCA)

The primary law governing food, drugs, medical devices, and cosmetics in the United States, granting the FDA authority to ensure these products are safe and effective.

Secretary of Health and Human Services (HHS)

The head of the U.S. Department of Health and Human Services, a cabinet-level position responsible for protecting the health of all Americans and providing essential human services.

Commissioner of Food and Drugs

The chief executive of the Food and Drug Administration (FDA), responsible for leading the agency's efforts to protect public health.

Prescribers

Healthcare professionals, such as doctors, physician assistants, and nurse practitioners, who are legally authorized to write prescriptions for medications.