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…defendants allegedly used a national marketing scheme to promote a fraud. If true, they should not get off scot-free if there is a practical statistical way to address the difficult…
…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!…
…(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”…
…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…
…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…
…that transmittal occurs after normal business hours. In the case of the PTE application for the ‘404 patent covering ANGIOMAX, that would mean the 60-day period would have begun on…
…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…
…drug as an “antibiotic” (see here). Second, there’s the recent fight over whether the St. Regis Mohawk Indian Tribe can use tribal sovereign immunity to shield patents covering RESTASIS from…
…notice of NDA approval of the drug product if that transmittal occurs after normal business hours. In the case of the PTE application for the ‘404 patent covering ANGIOMAX, that…
…Mid-Level Practitioner $731 $888 $157 Current and New Fees for Annual Cycle Registrants Registrant Category Current Annual Fee New Annual Fee Increase Per Year…
…legal parameters of DTC marketing, including “new media” TRACK state legislative initiatives and HARMONIZE inconsistent state obligations Additional details and registration information are available at www.AmericanConference.com/MedicalDevices or by calling 888-224-2480….
…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…
…be identified in various ways, including through guidance, special controls, and classifications, as well as by individual reviewers on a case by case basis. The latter method is troubling. The…
…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…
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…