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…in combination with” the other products sold by the company. Id. at 18-19. For those reasons and others, the Commission denied the Respondents’ appeal and issued a final Order requiring…
…qui tam actions. See e.g., United States ex rel. Rost v. Pfizer, Inc., 446 F.Supp. 6 (D. Mass 2006), a ruling later affirmed by the U.S. Court of Appeals for…
…user fees. Thus, for such companies, FDA’s costs remain static while the total amount of fees paid by the company continues to grow, eventually leading to an overage. The FDA…
…is waiting to hear from you, so provide your comments before the docket closes in February. In the words of the esteemed Dr. Frasier Crane, the USPTO says: “I’m listening.”…
…and order FDA to suspend ANDA approval. Valeant also seeks a Temporary Restraining Order (“TRO”) compelling FDA to suspend ANDA approval. (Valiant’s TRO is filed under seal.) FDA, as the…
…approve the company’s ANDA for a generic version of Abbott Laboratories’ DEPAKOTE (divalproex sodium) Delayed-Release Tablets, 500 mg. In January 2008, the U.S. District Court for the District of Columbia…
…however, visitors to FDA’s website may suggest new entries. (How about “AAD” – Acronyms and Abbreviations Database?) Click here for previous FDA Law Blog “Lighter Side” posts. By Kurt R….
…has reason to know” that the prescription is invalid. Holiday CVS, L.L.C. d/b/a CVS/Pharmacy, Nos. 219 and 5195; Decision and Order, 77 Fed. Reg. 62,316, 62,342 (Oct. 12, 2012). “[W]hen…
…scratching their heads and unsure as to what FDA expects in EUAs moving forward. The next “FDA Virtual Townhall” is Wednesday March 24th at 12:15 pm (ET). See you there….
…of a drug’s price offered to health plans. The complaint seeks a ruling that the amendment is invalid and an injunction against its implementation. ¶¶ 49-63. 2. CMS Proposes to…
…in fines. Things will heat up this summer if the trial begins in August, as currently scheduled. *Admitted to Maryland Bar. Work supervised by the Firm pending D.C. Bar Admission….
…agency action, and therefore not subject to court review. “‘The compliance order is not ‘final agency action.’ See 5 U.S.C. 704. A[n] . . . order marks only a step in…
…notice and comment rulemaking. HHS is rescinding all guidance documents and informal statements of policy concerning LDTs. HHS said that it made this decision “as part of the HHS’s ongoing…
…how much preclinical and preliminary clinical evidence is available and how compelling it is. FDA also encourages sponsors to use an independent data monitoring committee (“DMC”) and take into consideration…
…opinion in PLIVA Inc. v. Mensing (Docket No. 09-993), Actavis Elizabeth, L.L.C. v. Mensing (Docket No. 09-1039), and Actavis, Inc. v. Demahy (Docket No. 09-1501). It happened at 10:15 AM….