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…the drug products. Indeed, several patents are listed in the Orange Book for each of the three drug products, including U.S. Patent Nos. 6,150,383, 6,211,205, 6,303,640, 6,303,661, 6,329,404, 6,890,898, 7,078,381,…
…of analysis. o If, however, a drug is compounded using ingredients other than bulk substances, then those ingredients must comply with USP/NF monograph, if applicable, and USP chapters on compounding (including…
…12743, 12744 (Mar. 8, 2011). In the interim, however, “in the interest of public health, FDA is publishing this notice under section 519(a)(1)(B)(i)(III), to clarify that, to the extent there…
…of Appeals for the D.C. Circuit (see our previous posts here and here). Following several extensions for filing its opening brief, on August 14, 2013, POM Wonderful LLC Roll Global,…
…requirements must be met: It is created or modified to comply with the order of a physician or dentist. In order to comply, the device necessarily deviates from an otherwise…
…wade through the various FDA-related acronyms, FDA has created an Acronyms and Abbreviations Database, beginning with “A-V” (arteriovenous) and ending with “YTD” (year to date). The database is not complete;…
…evaluate “the potential for a device to lead to a clinical improvement in the diagnosis, treatment (including monitoring of treatment), cure, mitigation, or prevention of life-threatening or irreversibly debilitating condition.”…
In the preemption world, “fraud on the FDA” cases are fairly common. As one court recently used the term, fraud on the FDA means a drug or a medical device…
…a patient or for research, teaching, or quality control.” The term includes “any nonradioactive reagent, reagent kit, ingredient, nuclide generator, accelerator, target material, electronic synthesizer, or other apparatus or computer…
…support the company’s position. Mylan’s petition acknowledges, however, that FDA’s regulations “would allow delisting after patent expiration,” but notes that the company is challenging FDA’s position that 180-day exclusivity ends…
…for panel rehearing and rehearing en banc. Several amicus briefs have been filed in the case in support of Caraco’s rehearing petition, including briefs from GPhA, Mylan, Teva, Apotex, and…
…2005, no first applicant’s ANDA has been approved. Also, on April 16, 2007, Bayer requested that the ‘769 patent be “delisted” as to Precose, i.e., they withdrew the patent information. …
…grew by a whopping 324 pages (83.72%). Well, here we are in Fall 2018, a little more than 6 years after our original “waistline” post, and the world has changed…
On November 16, 2017, FDA released four guidance documents that, together, the Agency described as a “comprehensive policy framework” for applying existing laws and regulations governing regenerative medicine products, including…
…hydroxyl, halo, haloalkyl, amino or nitro groups; Substitution in or on the piperidine ring with alkyl, alkenyl, alkoxyl, ester, ether, hydroxyl, halo, haloalkyl, amino or nitro groups; Replacement of the…