Subpart H—Accelerated Approval of New Drugs for Serious or Life-Threatening Illnesses
Sections
Section numbering in the official eCFR can be non-consecutive. Omitted section numbers are not treated here as reserved unless the source explicitly labels them that way.
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314.500
§ 314.500 Scope. -
314.510
§ 314.510 Approval based on a surrogate endpoint or on an effect on a clinical endpoint other than survival or irreversible morbidity. -
314.520
§ 314.520 Approval with restrictions to assure safe use. -
314.530
§ 314.530 Withdrawal procedures. -
314.540
§ 314.540 Postmarketing safety reporting. -
314.550
§ 314.550 Promotional materials. -
314.560
§ 314.560 Termination of requirements.