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By Jamie K. Wolszon – ReGen Biologics, Inc. (“ReGen”) has petitioned the U.S. Court of Appeals for the District of Columbia Circuit (“D.C. Circuit”) to review the Center for Devices…
…these practices. In addition, the FTC alleges that the companies scammed consumers out of $30 million or more in 2009. The FTC plans to seek a permanent injunction against the defendants….
…sales programs. This D.C. Circuit decision comes just before this deadline – right in time for the withdrawal to take effect as scheduled. As we explained in a 2014 blog…
…whether the requirements in sections 53(b)(1) and (2) are satisfied. See, e.g. F.T.C. v. Virginia Homes Manufacturing Corp., 509 F. Supp. 51 (D. Md. 1981) (noting in dicta that it…
…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…
…only that the applicant can “elect[] to accept the opportunity for hearing. . . ” upon receipt of a CRL. After a series of a briefings, the D.C. Circuit motions…
…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…
…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….
…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…
…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…
…it did eventually issue proposed rules establishing OTC hearing aids in October 2021, after President Biden issued an Executive Order in July 2021 commanding publication. The Comment Period for those…