Title 21

PART 316 SUBPART D

Subpart D - Orphan-drug Exclusive Approval

• 21 U.S.C. 360aa, 360bb, 360cc, 360dd, 371.
• 57 FR 62085, Dec. 29, 1992, unless otherwise noted.

21:5.0.1.1.6.4.1.1	SECTION 316.31	316.31 Scope of orphan-drug exclusive approval.
21:5.0.1.1.6.4.1.2	SECTION 316.34	316.34 FDA recognition of exclusive approval.
21:5.0.1.1.6.4.1.3	SECTION 316.36	316.36 Insufficient quantities of orphan drugs.

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