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…are of domestic origin” Anticipating a large number of comments, FSIS has opened a docket on regulations.gov where comments may be submitted. Comments should be submitted by August 17, 2018….
…in the Act, please contact: Michelle L. Butler, mbutler@hpm.com, 202-737-7551 Alan M. Kirschenbaum, akirschenbaum@hpm.com, 202-737-4283 Jeffrey N. Wasserstein, jwasserstein@hpm.com, 202-737-9627 David C, Gibbons, dgibbons@hpm.com, 202-737-4286 Serra J. Schlanger, sschlanger@hpm.com, 202-737-4593…
…Pharm. USA, Inc. v. FDA, No. 99-5287, 2000 U.S. App. LEXIS 38667 (D.C. Cir. Nov. 15, 2000) (“Teva II”). FDA believed that as a result of the Teva I and…
…as Justice Breyer commented during the argument, “Blue brief I think you’re right. Red brief I think you’re right. You can’t both be right. That’s right. Alright. You see, that’s…
…USA, Inc. v. Sebelius, 595 F.3d 1303 (D.C. Cir. 2010), which is also at the heart of another Petition for Writ of Certiorari) and “effectively nullifies both a critical provision of…
…(W.D.N.Y. July 29, 2010) (No. 10-cv-587); Consent Decree, United States v. Jason Pharms, Inc., (D.C. Cir. 2012) (No. 12-1476), ECF No. 3. Thus, in response to the Bayer decision (following…
…Fed. Reg. 14,119 (Mar. 21, 2003). The rules together classified all naturally-occurring THC intended for human consumption as a Schedule I controlled substance. HIA challenged the DEA final rules and,…
…of 180-day exclusivity. See, e.g., Ranbaxy Labs., Ltd. v. Leavitt, 459 F. Supp. 2d 1, 3-4 (D.D.C. 2006). Ultimately, we cannot Predict whether the Amarin case will be settled or,…
…periods. But President Biden wants that to change. In the July 2021 Executive Order on Promoting Competition in the American Economy, the White House noted that patent laws “have been…
…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…
…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…
…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…
…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….
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…
…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…