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  2. Prescription drug - Wikipedia

    en.wikipedia.org/wiki/Prescription_drug

    A prescription drug (also prescription medication, prescription medicine or prescription-only medication) is a pharmaceutical drug that is permitted to be dispensed only to those with a medical prescription. In contrast, over-the-counter drugs can be obtained without a prescription.

  3. Food and Drug Administration - Wikipedia

    en.wikipedia.org/wiki/Food_and_Drug_Administration

    The United States Food and Drug Administration (FDA or US FDA) is a federal agency of the Department of Health and Human Services.The FDA is responsible for protecting and promoting public health through the control and supervision of food safety, tobacco products, caffeine products, dietary supplements, prescription and over-the-counter pharmaceutical drugs (medications), vaccines ...

  4. Prescription Drug User Fee Act - Wikipedia

    en.wikipedia.org/wiki/Prescription_Drug_User_Fee_Act

    The Prescription Drug User Fee Act (PDUFA) was a law passed by the United States Congress in 1992 which allowed the Food and Drug Administration (FDA) to collect fees from drug manufacturers to fund the new drug approval process.

  5. Medication - Wikipedia

    en.wikipedia.org/wiki/Medication

    A medication (also called medicament, medicine, pharmaceutical drug, medicinal product, medicinal drug or simply drug) is a drug used to diagnose, cure, treat, or prevent disease. [ 1 ] [ 2 ] Drug therapy ( pharmacotherapy ) is an important part of the medical field and relies on the science of pharmacology for continual advancement and on ...

  6. PDUFA date - Wikipedia

    en.wikipedia.org/wiki/PDUFA_date

    The Prescription Drug User Fee Act was first passed in 1992 to facilitate the funding of the Food and Drug Administration while ensuring a more predictable timetable for drug approvals. [3] Under the PDUFA regime, New Drug Applications and Biologics License Applications (together referred to as 'human drug applications' in the PDUFA context ...

  7. Medical prescription - Wikipedia

    en.wikipedia.org/wiki/Medical_prescription

    The prescription symbol, ℞, as printed on the blister pack of a prescription drug. A prescription, often abbreviated ℞ or Rx, is a formal communication from physicians or other registered healthcare professionals to a pharmacist, authorizing them to dispense a specific prescription drug for a specific patient.

  8. Boxed warning - Wikipedia

    en.wikipedia.org/wiki/Boxed_warning

    It is the strongest warning that the FDA requires, and signifies that medical studies indicate that the drug carries a significant risk of preventable, serious or even life-threatening adverse effects. [2] [3] Economists and physicians have thoroughly studied the effects of FDA boxed warnings on prescription patterns.

  9. Durham–Humphrey Amendment - Wikipedia

    en.wikipedia.org/wiki/Durham–Humphrey_Amendment

    Legend drugs must be dispensed with direct medical supervision, but over-the-counter drugs can be purchased and used without a prescription. The law also legalized verbal transmission of prescriptions and provided for the legal right of a pharmacist to refill prescriptions as indicated in a provider's initial prescription.

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