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Code of Federal Regulations
Title 21
Chapter I
Subchapter D
Part 316
21 C.F.R. Part 316
Orphan Drugs
A
General Provisions
B
Written Recommendations for Investigations of Orphan Drugs
C
Designation of an Orphan Drug
D
Orphan-drug Exclusive Approval
E
Open Protocols for Investigations
F
Availability of Information
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