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Understanding the Orphan Drug Credit The Orphan Drug Credit, established under the Orphan Drug Act of 1983, is a federal tax incentive aimed at encouraging pharmaceutical companies to invest in research and development (R&D) for treatments of rare diseases that affect fewer than 200,000 individuals in the United States. The
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What is the Orange Book? The Orange Book, also known as Approved Drug Products with Therapeutic Equivalence Evaluations, is an essential resource for medical professionals, researchers, and patients alike in the pharmaceutical industry. This publication by the U.S. Food and Drug Administration (FDA) lists all approved drugs that have undergone
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Background of the FDA Established in 1906 following the passage of the Federal Food and Drugs Act, the U.S. Food and Drug Administration (FDA) is a critical government entity responsible for overseeing multiple sectors that include food, drugs, cosmetics, animal food, dietary supplements, medical devices, biological goods, and blood products.
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