21 U.S.C. § 360dd — Open protocols for investigations of drugs for rare diseases or conditions

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 condition who need the drug to treat the disease or condition and who cannot be satisfactorily treated by available alternative drugs. (June 25, 1938, ch. 675, § 528, as added Pub. L. 97–414, § 2(a) , Jan. 4, 1983 , 96 Stat. 2051 .) CFR Title Parts 21 5 , 7 , 10 , 11 , 12 , 13 , 14 , 15 , 16 , 20 , 25 , 99 , 316

Related documents

• 21 CFR Part 316 — Orphan Drugs#506816
• 21 CFR Part 99 — Dissemination of Information on Unapproved/New Uses for Marketed Drugs, Biologics, and Devices#506729
• 21 U.S.C. § 360bbb-0 — Expanded access policy required for investigational drugs#577310
• Interpol review of forensic drug chemistry, 2022-2025.#480828
• 21 CFR Part 314 — Applications for FDA Approval to Market a New Drug#506814