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…product for reasons other than sale within the control of the manufacturer or application holder.” Hmmmm . . . . . This is not the first time Connecticut has put…
…U.S. Department of Health and Human Services et al., Case No. 1:12-cv-01592. As we previously reported, the District Court granted Depomed’s Motion for Summary Judgment and ordered FDA to recognize…
By Kurt R. Karst & Michelle L. Butler – Ever since FDA withdrew a notice of appeal in Depomed Inc. v. U.S. Department of Health and Human Services et al.,…
…C.F.R. part 50 pursuant to 21 C.F.R. 312.60 and 21 C.F.R. 50.20. Failing to obtain informed consent from subjects who were enrolled. Enrolling subjects and giving them investigational drug before…
…what is commonly referred to as an “industry working group” (IWG) that has worked together to develop a proposal for the single, shared REMS. . . . FDA has typically…
…prescription.): (a) PRIORITY REVIEW OF APPLICATION.—Thc Secretary of Health and Human Services. . . shall give priority review to any supplemental application submitted under [FDC Act § 505(b)] for a…
…our policy effort has not been commensurate with the complexity of the problem. . . . [C]onsumer advocates want prices to be as low as they can be, as soon…
…data, and FDA laboratory tests . . . have raised concerns that the products may not produce the same therapeutic benefits for some patients as the brand-name product, Concerta. ….
…it’s clearly an issue FDA has considered and believes is consistent with the law. With complex merger and acquisition deals, companies should not forget about this possibility . . ….
…The MAPP has been under development for quite some time . . . . and there’s a lot of history behind it. And although the “Background” section of the MAPP…
…initially to satisfy the statutory requirements. It is clear that the application must include several components—enumerated immediately above. See 21 U.S.C. § 355(b)(1). But it is not clear from the…
By Kurt R. Karst – Last week, Elliott Associates, L.P., Elliott International, L.P. and Knollwood Investments, L.P. (collectively “Elliott”), a hedge fund with investment interests in Takeda Pharmaceuticals U.S.A., Inc.’s…
…. . . but nothing was released by FDA. Of course, we had lots to keep us busy in the interim. In particular, there was FDA’s October 6, 2016 publication…
…U.S.C. § 355a(d)(3) . . . shall be deemed to relate back, nunc pro tunc, to May 22, 2017, the date of FDA’s initial determination.” As we previously explained, a…
…021654. But, of course, in reality, the issue is much more . . . shall we say . . . complex than the nutshell description, because FDA needed to address…