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…sought. . . .” Teva’s Complaint requested declaratory and injunctive relief. Shortly after the March 2, 2010 decision was issued, Teva filed an Emergency Motion To Issue Mandate Forthwith, because…
…cases that weren’t first of their kind or that did not include sensitive personal health information include, among many others, Facebook ($90m, $725m and $5b), YouTube ($170m), Capital One ($190m),…
…with the use of the drug are discovered.” 44 Fed. Reg. 37434, 37447 (June 26, 1979); see also CDER, Manual of Policies and Procedures (MAPP) 6020.10, NDAs: “Dear Health Care…
…after June 29, 2001, and no later than July 20, 2001, the date of the next database update.” As such, “at the time Teva submitted its ANDA, the electronic Orange…
…civil contempt proceedings against Mr. Trudeau, arguing that he had violated a 2004 Consent Order’s command that he not misrepresent the content of his book. FTC v. Trudeau, No. 08-4249,…
…of promotional activity, including package inserts, pamphlets, mailing pieces, fax bulletins, reprints of press releases, and all other literature that supplements, explains, or is otherwise textually related to the product.”…
…order to meet this designation, Standard 2, Resolution of Personal Conflicts of Interest of the ACCME Standards for Commercial SupportSM would be fulfilled by recusal. That is, no person who…
…statutory language, the judge in Minnesota overseeing multi-district device litigation granted the plaintiffs’ motion to amend their complaint to comply with the Court’s recent ruling in Wyeth v. Levine. The…
By Jeffrey N. Wasserstein & William T. Koustas – On November 12, 2008, Senate Finance Committee Chairman Max Baucus released a white paper detailing what he sees as the substantial…
…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…
…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…
…to help companies comply with FDA’s requirements. That strategy has failed, too. The new idea is for NIH’s ITAP program to pivot to serial screening. NIH has been in communication…
…non-controlled prescription drugs into the United States. Google has agreed to pay $500 million as a civil forfeiture in order to resolve this matter. The government claims that, since 2003,…
End-of-Phase 2 (EOP2) is, in our view, one of the most critical moments in drug development. It’s the moment at which a drug sponsor selects, and seeks FDA agreement on,…