human generic drug activities

(9) The term “human generic drug activities” means the following activities of the Secretary associated with generic drugs and inspection of facilities associated with generic drugs: (A) The activities necessary for the review of generic drug submissions, including review of drug master files referenced in such submissions. (B) The issuance of— (i) approval letters which approve abbreviated new drug applications or supplements to such applications; or (ii) complete response letters 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 issuance of letters related to Type II active pharmaceutical drug master files which— (i) set forth in detail the specific deficiencies in such submissions, and where appropriate, the actions necessary to resolve those deficiencies; or (ii) document that no deficiencies need to be addressed. (D) Inspections related to generic drugs. (E) Monitoring of research conducted in connection with the review of generic drug submissions and drug master files. (F) Postmarket safety activities with respect to drugs approved under abbreviated new 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) insofar as those activities relate to abbreviated new drug applications. (v) Carrying out section 355(k)(5) of this title (relating to adverse-event reports and postmarket safety activities). (G) Regulatory science activities related to generic drugs.


21 USC § 379j-41(9)

Scoping language

For purposes of this subpart
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