Part 316. PART 316—ORPHAN DRUGS

• SUBPART A [§ 316.1 - § 316.4] - Subpart A—General Provisions
• SUBPART B [§ 316.10 - § 316.14] - Subpart B—Written Recommendations for Investigations of Orphan Drugs
• SUBPART C [§ 316.20 - § 316.30] - Subpart C—Designation of an Orphan Drug
• SUBPART D [§ 316.31 - § 316.36] - Subpart D—Orphan-drug Exclusive Approval
• SUBPART E [§ 316.40 - § 316.40] - Subpart E—Open Protocols for Investigations
• SUBPART F [§ 316.50 - § 316.52] - Subpart F—Availability of Information