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Orphan diseases and orphan drugs: infant botulism and BIG-IV

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The problem is that developing new treatments for rare diseases is not commercially attractive to drug companies. The response in the USA was the Orphan Drug Act of 1982. An orphan drug is defined as one produced with the aim of treating a disease that affects fewer than 200 000 people in the USA or one that will probably not produce a profit within 7 years of FDA approval. The Act provides …

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