process for the review of human drug applications

(6) The term “process for the review of human drug applications” means the following activities of the Secretary with respect to the review of human drug applications and supplements: (A) The activities necessary for the review of human drug applications and supplements. (B) The issuance of action letters which approve human drug applications or which set forth in detail the specific deficiencies in such applications and, where appropriate, the actions necessary to place such applications in condition for approval. (C) The inspection of prescription drug establishments and other facilities undertaken as part of the Secretary’s review of pending human drug applications and supplements. (D) Activities necessary for the review of applications for licensure of establishments subject to section 262 of title 42 and for the release of lots of biologics under such section. (E) Monitoring of research conducted in connection with the review of human drug applications. (F) Postmarket safety activities with respect to drugs approved under human drug applications or supplements, including the following activities: (i) Collecting, developing, and reviewing safety information on approved drugs, including adverse event reports. (ii) Developing and using improved adverse-event data-collection systems, including information technology systems. (iii) Developing and using improved analytical tools to assess potential safety problems, including access to external data bases. (iv) Implementing and enforcing section 355(o) of this title (relating to postapproval studies and clinical trials and labeling changes) and section 355(p) of this title (relating to risk evaluation and mitigation strategies). (v) Carrying out section 355(k)(5) of this title (relating to adverse event reports and postmarket safety activities).


21 USC § 379g(6)

Scoping language

For purposes of this subpart
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