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…drug patent settlement agreements (here), user fees (here), orphan drugs (here), or just general FDA regulation (here). We find it all rather interesting. After all, data can provide an informative…
…voluntarily provide timely notice of approval of any ANDA for a generic version of Seroquel or Seroquel XR to AstraZeneca and the Court, even if this case were dismissed without…
…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…
…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…
…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…
…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…
…(“the ‘338 patent”), which covers AstraZeneca’s PRILOSEC OTC (omeprazole magnesium) Delayed-Release Tablets, is not eligible for a PTE on the same two statutory bases. In both cases, AstraZeneca has challenged…
…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…
…approval). In April 2007, the U.S. Patent and Trademark Office (“PTO”) denied the PTE request. Among other things, the PTO cited Unimed, Inc. v. Quigg, 888 F2d 826; 12 USPQ2d…
…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…
…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”…
…a not-for-profit, global organization dedicated to bringing health care product development professionals together in a neutral environment to improve health and well-being throughout the world. The conference focuses on the…
…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….
…automatic construction and auto-filling content; content and structure that is complementary to CDRH internal review templates; integration with FDA databases and guidance documents; and automatic verification. While eSubmitter is a…