21 CFR Part 316
ORPHAN DRUGS
June 25, 2020
Subpart
B
Written Recommendations for Investigations of Orphan Drugs
Subpart
A
General Provisions
Subpart
C
Designation of an Orphan Drug
Subpart
D
Orphan-drug Exclusive Approval
Subpart
E
Open Protocols for Investigations
Subpart
F
Availability of Information
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