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…deliberate or accidental),” because that rule would “allow the executive to torpedo otherwise valid legislation simply by failing to cite . . . the interests on which Congress relied.” Congress…
…May 2013 (see our previous post here). USDA gave industry until November 2013 to comply. The American Meat Institute (“AMI”) and others filed a complaint and request for preliminary…
…from Abbott Point of Care in Ottawa, Canada. “We all have access to similar information from the government (e.g., FDA draft guidances, etc.) but this blog not only explains the…
By David C. Gibbons & Alan M. Kirschenbaum – At 3 am on October 30, 2015, the Senate passed H.R. 1314, the Bipartisan Budget Act of 2015 (“BBA”), which had…
…compelled commercial speech. This type of speech is not subject to the strict scrutiny standard. In fact, “when the compelled speech is commercial and purely factual in nature, the speaker’s…
…briefs for all parties are available here, here, here, and here. PREVOR was represented by Hyman, Phelps & McNamara, P.C. (attorneys Jeffrey N. Gibbs, John R. Fleder, Jennifer M. Thomas,…
…agricultural commodities; macadamia nuts; pecans; ginseng; and peanuts. AMS published a final rule for all covered commodities on January 15, 2009, which took effect on March 16, 2009. The authorization…
…certiorari in Merck & Co., Inc. v. Louisiana Wholesale Drug Company, Inc. (Docket Nos. 12-245) and Upsher-Smith Laboratories, Inc. v. Louisiana Wholesale Drug Company, Inc. (Docket No. 12-265) concerning K-DUR…
By Kurt R. Karst – Last Friday afternoon, Endo Pharmaceuticals Inc. (“Endo”) filed a Complaint and a Motion for Preliminary Injunction in the U.S. District Court for the District of…
…“[i]t is not acceptable to use an approved Canadian drug product . . . .” Roxane’s Counterclaim Complaint alleges violations of, among other things, Sections 1 and 2 of the…
…be consumed on occasion for reasons other than taste, aroma, or nutritive value.”); American Health Products Co., Inc. v. Hayes, 574 F. Supp. 1498, 1507 (S.D.N.Y. 1983), aff’d, 744 F.2d…
…in nature. In fact, you only have 500 characters to say why you’re a fan of the blog. Remember, when you complete the nomination form, our URL is www.fdalawblog.net. Friend-of-the-blawg…
…of Dockets Management (via http://www.regulations.gov) at any time. But to ensure that your comments are considered prior to finalizing the draft guidance, you should submit them by November 16, 2012.…
…(something pithy). Remember, when you complete the nomination form, our URL is www.fdalawblog.net. Friend-of-the-blawg briefs are due no later than Friday, September 7th. ABA editors make the final decisions about…
…will be considered “initiated” prior to the compliance date, and the new statement will not be required in the informed consent documents. Guidance, p. 4. FDA also explains that any…