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In re Incretin-Based Therapies Prods. Liab. Litig.
- United States
- U.S. District Court — Southern District of California
- November 9, 2015
...have an ongoing duty to report the results of studies and drug surveillance to the FDA. 21 U.S.C. § 355(k)(1) ; 21 C.F.R. §§ 314.80, 314.81 ; Dobbs, 797 F.Supp.2d at 1270 ("After a drug is approved by the FDA, manufacturers are required to maintain records, conduct additional testing as dir......