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…“clarify the procedures a registrant must follow” to identify and report suspicious orders. Suspicious Orders of Controlled Substances, Notice of Proposed Rulemaking, 85 Fed. Reg. 69,282 (Nov. 3, 2020). DEA’s…
…to the repository of final orders. FDA intends to make the deemed final orders available in batches on a rolling basis until all 32 orders are available in the repository….
…the customer selling the order.” While this “clarification” is indeed welcome, it surely was not readily ascertainable from either the PDDA’s, or Section 1301.74(b)’s definition of “suspicious order.” DEA’s suspicious…
…of service of the Order to Show Cause. A third option is to ignore the Order to Show Cause, in which case DEA will request a final order based only…
…potential cardioprotective effect of EPA, “would be neither false nor misleading.” Op. and Order at 55, Amarin Pharma, Inc. v. FDA, No. 15-3588 (S.D.N.Y. Aug. 7, 2015) (“August 7 Order”)….
…order restricting Canadian sellers from distributing drugs outside of Canada. The Executive Order places the Biden Administration firmly behind drug importation. Although the Order is careful to repeat Section 804’s…
…label claims. For false or misleading qualified MUSA claims, FTC authority remains limited to injunctive relief. It includes a list of equivalents to “Made in USA” in 16 C.F.R. §…
…and require that any beef product labeled as “Made in the USA,” “Product of the USA,” “USA beef,” or otherwise indicated to be U.S. beef, come from cattle that have…
…Quality, Certification and Oversight Reports (QCOR), Active CLIA Laboratory Search Database, https://qcor.cms.gov/advanced_find_provider.jsp?which=4&backReport=active_CLIA.jsp. [4] PRIA at 28. [5] Id. at 75. [6] 88 Fed. Reg. 68006, 68012 (Oct. 3. 2023) (hereinafter…
…the “Self-Certification and Employee Training of Mail-Order Distributors of Scheduled Listed Chemical Products.” See 76 Fed. Reg. 20,518 (Apr. 13, 2011). The Interim Rule implements the Combat Methamphetamine Enhancement Act…
…claims on product labels. Interestingly, the rule extends beyond claims made on product labels to Made in the USA claims appearing in “mail order catalogs or mail order advertising.” That…
…statute is ambiguous under Chevron U.S.A., Inc. v. Nat. Res. Def. Council, 467 U.S.837 (1984), given the prior understanding of the law by the Supreme Court, the Court cannot find,…
…with Plaintiffs’ request is irrelevant to Defendants’ counterclaims. The statutory remedy is limited to requiring the patent holder—i.e., Plaintiffs—to correct or delete patent information . . . . The statute…
…the customer can place an order” (emphasis added) includes an establishment’s homepage (e.g., www.CafeEtan.com), or only the specific webpage from which customers can place an order (e.g., www.CafeEtan.com/order). It is also…
…FDA decided to revoke the 2008 order. See 73 Fed. Reg. 71923 (Nov. 26, 2008). The majority of the comments felt that the 2008 order was too broad in scope, would…