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…2009 ruling in Shire Labs, Inc. v. CorePharma, LLC, C.A. 06-2266 (D.N.J.), in which the court entered a final judgment of its previous order granting CorePharma’s motion for summary judgment…
…action failed to reasonably cooperate in expediting the action . . . .” FDC Act § 505(j)(5)(B)(iii). As we previously reported, in May 2008, Sandoz submitted an ANDA to FDA…
…the communication of a “determination” within 20 working days of an agency receiving the request (5 U.S.C. § 552(a)(6)(A)(i)), or within 30 working days in “unusual circumstances” (5 U.S.C. §…
…Prescription Drugs from International Mail Order Prescription Pharmacies,” 2013 Me. Legis. Serv. Ch. 373 (S.P. 60) (L.D. 171) (West) (the “2013 Act”), went into effect on October 9, 2013, and…
…activities. Note that Immediate Suspension Orders permit DEA to bypass the typical Show Cause process and suspend a DEA registration without notice or a hearing. H.R. 471, titled “Ensuring Patient…
…Apotex’s Complaint for lack of a case or controversy. Citing and quoting the U.S. Supreme Court’s decision in MedImmune, Inc. v. Genentech, Inc., 549 U.S. 118 (2007), the Federal Citcuit…
…2003 Medicare Modernization Act (“MMA”), Pub. L. No. 108-173, 117 Stat. 2066, and 12 years and about 10 months after the MMA’s enactment, we finally have new Hatch-Waxman regulations. On…
Hyman, Phelps & McNamara, P.C. is co-hosting a complimentary webinar, with Five Rivers Rx, on DEA compliance during the current opioid epidemic. The webinar is scheduled for November 15, 2018…
…Justice) filed an injunction suit against Franck’s Lab, Inc. and others (collectively “Franck’s”) in the Middle District of Florida. Franck’s compounds veterinary drugs for non-food producing animals. On July 1,…
…for an individually identified patient. Section 503A has always permitted compounders to compound copies of shortage medications (which are not, by definition, “essential copies” of commercially available drug products). Never…
As unfortunately happens during every national disaster or emergency, unscrupulous individuals and companies see an opportunity to make money. A lot of it. When that happens, there are always immediate…
…one of administrative orders. Instead of rulemaking which would take six or more years, FDA expects that the administrative orders process can be completed in less than two years. Moreover,…
…v. Brown, No. 2:17-cv-02573 (E.D. Cal. Jan. 26, 2018) (quoting Friends of the Earth, Inc. v. Laidlaw Envtl. Servs., Inc., 528 U.S. 167, 181 (2000)). The court held that PhRMA’s…
…regulatory issues and questions. Under the Food and Drug Administration Reauthorization Act and the MDUFA IV Commitment Letter, certain changes were made to the Pre-Submission program. Most of these were…
…2018, the Acting Administrator revoked the registrations of Trinity Pharmacy I, 83 Fed. Reg. 7220 (Feb. 20, 2018), and Trinity Pharmacy II, 83 Fed. Reg. 7304 (Feb. 20, 2018). Then…