PART 316—ORPHAN DRUGS
Editorial Note:
Nomenclature changes to part 316 appear at 69 FR 13717, Mar. 24, 2004.
Subparts
-
A
Subpart A—General Provisions Sections 316.1–316.4 -
B
Subpart B—Written Recommendations for Investigations of Orphan Drugs Sections 316.10–316.14 -
C
Subpart C—Designation of an Orphan Drug Sections 316.20–316.30 -
D
Subpart D—Orphan-drug Exclusive Approval Sections 316.31–316.36 -
E
Subpart E—Open Protocols for Investigations Section 316.40 -
F
Subpart F—Availability of Information Sections 316.50–316.52