21 U.S.C. § 360dd Open Protocols For Investigations of Drugs For Rare Diseases Or Conditions

• Library: United States Statutes
• Edition: 2023
• Currency: Current through P.L. 118-21 (published on www.congress.gov on 11/13/2023)

If a drug is designated under section 360bb of this title as a drug for a rare disease or condition and if notice of a claimed exemption under section 355(i) of this title 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 condi...