Sections 525 to 528Drugs for Rare Diseases or Conditions

These sections are the result of the Orphan Drug Act of 1983. The Pharmaceuticals that are covered are for diseases or conditions that are rare in the United States. A "rare disease or condition" is defined as any disease or condition that (i) affects less than 200,000 persons in the U.S. or (ii) affects more than 200,000 persons in the U.S. for which there is no reasonable expectation that the cost of developing and making the drug available will be recovered from U.S. sales. This section further explains that a manufacturer or sponsor needs to request that a drug be designated for a rare disease or condition before the submission of an application under Section 505(b).

For a drug that is given orphan drug status, the expectations are that similar clinical pharmacology and biopharmaceutics information would be provided in an NDA as that for a drug that is not given the orphan drug status.

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