PART 316—ORPHAN DRUGS
- SUBPART A—General Provisions (§316.1 to §316.4)
- SUBPART B—Written Recommendations for Investigations of Orphan Drugs (§316.10 to §316.14)
- SUBPART C—Designation of an Orphan Drug (§316.20 to §316.30)
- SUBPART D—Orphan-drug Exclusive Approval (§316.31 to §316.36)
- SUBPART E—Open Protocols for Investigations (§316.40 to §316.40)
- SUBPART F—Availability of Information (§316.50 to §316.52)