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…when The White House OSTP issued a document per Executive Order 14081, titled “Bold Goals for U.S. Biotechnology and Biomanufacturing; Harnessing Research and Development to Further Societal Goals.” One component…
By Riëtte van Laack & John R. Fleder – After the Federal Trade Commission (“FTC”) entered consent orders against Nestle and Iovate (see here), prohibiting future claims for respondents’ food…
By Kurt R. Karst – Last Friday, ViroPharma Incorporated (“ViroPharma”) filed a Complaint and a Motion for Temporary Restraining Order And/Or Preliminary Injunction in the U.S. District Court for the…
…Count IV fails to state a claim under [FDC Act § 801(a)] because the complaint does not allege that the policy is illegal. . . . [T]he complaint is devoid…
…permitted by the doctrine of res judicata. See Jose G. Zavaleta, M.D.; Decision and Order, 78 Fed. Reg. 27,431 (May 10, 2013). Second, the decision states that the government argued…
…practice.” 21 U.S.C. § 353(f)(1). Generally, an “order” is “lawful” if it is a prescription or, if an oral order, it is both promptly reduced to writing and filed by…
…less than 2,300 mg (and to 1,500 mg for certain at-risk populations), consume less than 300 mg per day of dietary cholesterol, limit foods containing synthetic sources of trans fats,…
…or need more information, contact: Frank J. Sasinowski, fsasinowski@hpm.com, 202-737-4287 Josephine M. Torrente, jtorrente@hpm.com, 202-737-7554 David B. Clissold, dclissold@hpm.com, 202-737-7545 James E. Valentine, jvalentine@hpm.com, 202-724-1745 Michelle L. Butler, mbutler@hpm.com, 202-737-7551…
…or need more information, contact: Frank J. Sasinowski, fsasinowski@hpm.com, 202-737-4287 Josephine M. Torrente, jtorrente@hpm.com, 202-737-7554 David B. Clissold, dclissold@hpm.com, 202-737-7545 James E. Valentine, jvalentine@hpm.com, 202-724-1745 Michelle L. Butler, mbutler@hpm.com, 202-737-7551…
…in court. In one case – Vermont v. Leavitt, 405 F. Supp. 2d 466 (D. Vt. 2005) – a federal court concluded that a state plan for importing drugs from…
…Congress.’” Arizona, 132 S. Ct. at 2501 (quoting Hines v. Davidowitz, 312 U.S. 52, 67 (1941)). Focusing on the Plaintiffs’ contention that the MPA Amendments violate the Supremacy Clause, U.S….
…with the 21 U.S.C. § 823(a) public interest factors and U.S. obligations under the Single Convention. 85 Fed. Reg. 82,334. DEA received 256 comments in response to its March 23,…
…Impax had to agree to a no-payment settlement . . . cannot undermine the Commission’s finding that a less restrictive settlement was viable.” Because evidence supported a reasonable factfinder to…
…Commonwealth from taking any action to implement or enforce the declaration and order. Though down, the Commonwealth was not out. Commonwealth officials went right to work after the district court’s…
…IVD. These topics have been extensively discussed already. NGS is playing an increasingly prominent role in research and diagnosis. Prior to releasing these draft guidances, FDA held three public meetings…