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…issue;” namely, approval of ANDA No. 201422. Enter the now familiar Federal Circuit decisions in Caraco Pharm. Labs. v. Forest Labs., 527 F.3d 1278 (Fed. Cir. 2008) and Janssen Pharmaceutica,…
…one of these portals, with the companies collecting regulatory property rights along the way. Some forms of this regulatory property are quasi-patent. Other forms are quasi-trade secret. Finally, some forms…
…35 U.S.C. § 156(d)(1) to effectively codify Judge Claude M. Hilton’s August 3, 2010 decision in The Medicines Company v. Kappos, 731 F. Supp. 2d 470 (E.D. Va. 2010), in…
…drug. See generally 72 Fed. Reg. 54228-29. Based on industry comments, the 2007 proposed rescheduling rule hit a road block in 2008. The DEA opted instead to require the application…
…n.3 (D.C. Cir. 1998); Mova Pharm. Corp. v. Shalala, 140 F.3d 1060, 1064 n.3 (D.C. Cir. 1998). Q7: What is the significance of January 1, 1982 to the Orange Book? FDC…
…they’re talking about. ATTORNEY: So am I, Your Honor. It’s just not me. Thank you. THE COURT: Thank you. A: Judge Roger W. Titus, U.S. District Court for the District…
Over the past few days there’s been an avalanche of FDA-related legislation introduced in both the U.S. House of Representatives and the U.S. Senate. Some of the bills introduced are…
…as reasonably practicable, according to a Court-ordered timeline.” They further ask that the Court retain jurisdiction to ensure compliance with the ordered time line. We will be monitoring further developments….
…applicant described in subclause (III) may not receive effective approval until 180 days after the first applicant begins commercial marketing of the drug. . . . (III) APPLICANT APPROVAL.—The Secretary…
…to come into compliance. What will ultimately happen to the TA or other IVD legislation is uncertain. Clearly, a new law will not be enacted this year. Given the competing…
…for women. We also heard from Dr. Suzanne Baron, Director of Interventional Cardiology Research at Lahey Hospital and Medical Center. Dr. Baron spoke to specific actions sponsors can take to…
…15 days (the same time as the RTA process), given the electronic nature, we hope this means a shorter administrative turnaround time compared to the RTA process. (A submitter has…
…the final condition, it’s not clear what “incentivizes . . . the manufacturer to submit a request” even means. Patent settlements, by their nature, incentivize competition by providing a date…
…report (here). On November 26, 2018, FDA Commissioner Dr. Scott Gottlieb and Dr. Jeffrey Shuren, Director of the Center for Devices and Radiological Health, announced that FDA is planning to…
…least 20 sec. using a cleaning compound in a hand washing sink. In contrast, in vivo testing for health care antiseptics requires 30 sec. contact. Causes of food borne illnesses…