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…(later amended) Allergan, Inc. (“Allergan”) filed alleging premature notice concerning generic RESTASIS (cyclosporine ophthalmic emulsion) 0.05%. Allergan was seeking, among other things, a “Declaratory Judgment of False Paragraph IV Notification”…
…practical real-world examples that will help you to excel in your everyday practices. Join the “Who’s Who” of the FDA Bar and don’t miss your opportunity to join their ranks!…
…review period occurred for commercial marketing or use” (i.e., within 60-days of the date of NDA approval). In April 2007, the PTO denied the PTE request. Among other things, the…
…patent is restored. The impact of patent restoration would be neutral to the federal budget during in the FY2009-FY2018 period, under the CBO assumptions, given the $65 million fee. Net…
…date after product approval. AstraZeneca cites several examples of PTEs allegedly granted since 1986 in which the PTE application for the subject patent was submitted to the PTO based on…
…Applications and 505(b)(2) Applications—Final Rule (the “MMA Final Rule”), 81 Fed Reg. 69580, 69609 (Oct. 6, 2016) (adopting proposed rule that applicants must “satisfy the notice requirement of the [Hatch-Waxman]…
…in the drug/biological product approval process SEE the importance of cGMPs to the post-approval regulatory process NAVIGATE the protocols of adverse events monitoring, pharmacovigilance, and Risk Evaluation and Minimization Strategies…
…things, the PTO cited Unimed, Inc. v. Quigg, 888 F2d 826; 12 USPQ2d 1644 (Fed. Cir. 1989), in which the Federal Circuit addressed the timeliness of a PTE application submission…
…FDA that would switch Narcan (naloxone) Nasal Spray from prescription to over-the-counter (OTC) status. All 19 members of the joint Advisory Committee agreed that the benefit-risk profile of Narcan Nasal…
…not withdrawn. Although Antares raised in its petition, among other things, choice of listed drug and pharmaceutical equivalence issues, all FDA needed to deny the petition was to answer one…
…OZO, OZP, OZQ) Auto injectors (when CDRH is lead Center; e.g., KZE, KZH, NSC ) Automated external defibrillators (e.g., MKJ, NSA ) Duodenoscopes (on the reprocessing; e.g., FDT) with elevator…
…checklist, but the general structure has been constant. This method of submission development allows for efficient development of each section and collaboration across numerous subject matter experts and internal reviewers….
By John R. Fleder – Although there are many areas where practitioners and others disagree regarding the FDC Act, there is at least one subject that seems to generate universal…
…not claim either – (aa) the drug for which the application was approved; or (bb) an approved method of using the drug. The MMA also added an almost identical counterclaim…
…in subclause (I) in any civil action or proceeding other than a counterclaim described in subclause (I). The MMA also added an almost identical counterclaim provision at FDC Act §505(c)(3)(D)(ii)…