If a drug is designated under as a drug for a rare disease or condition and if notice of a claimed exemption under or regulations issued thereunder is filed for such drug, the Secretary shall encourage the sponsor of such drug to design protocols for clinical investigations of the drug which may be conducted under the exemption to permit the addition to the investigations of persons with the disease or condition who need the drug to treat the disease or condition and who cannot be satisfactorily treated by available alternative drugs.
Structure US Code
CHAPTER 9— FEDERAL FOOD, DRUG, AND COSMETIC ACT
SUBCHAPTER V— DRUGS AND DEVICES
Part B— Drugs for Rare Diseases or Conditions
§ 360aa. Recommendations for investigations of drugs for rare diseases or conditions
§ 360bb. Designation of drugs for rare diseases or conditions
§ 360cc. Protection for drugs for rare diseases or conditions
§ 360dd. Open protocols for investigations of drugs for rare diseases or conditions
§ 360ee. Grants and contracts for development of drugs for rare diseases and conditions
§ 360ee–1. FDA rare neurodegenerative disease grant program
§ 360ff. Priority review to encourage treatments for rare pediatric diseases