Glossary

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Term of the Day

Informed consent

Informed consent is the process in which a health care provider educates a patient about the risks, benefits, and alternatives of a given procedure or intervention. The patient must be competent to make a voluntary decision about whether to undergo the procedure or intervention.

O

Orphan Drug Designation (ODD)

An Orphan Drug Designation (ODD) is a regulatory designation granted by the FDA (Food and Drug Administration) in the United States, and similar agencies in other countries, to drugs and biologics that are intended to treat rare diseases or conditions.The Orphan Drug Act was passed in the United States in 1983 to encourage the development of drugs for rare diseases, defined as those affecting fewer than 200,000 individuals in the U.S. Orphan Drug Designation provides various benefits to drug developers, including tax credits, grants for clinical trials, and a period of market exclusivity for the drug if it is approved by the FDA.

To receive Orphan Drug Designation, a drug must meet specific criteria established by the FDA, including the rarity of the disease or condition it is intended to treat, and the potential for the drug to provide significant clinical benefit over existing therapies.

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