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…the application. Such an understanding is critical to addressing the review division’s findings through additional data or analyses, and is even more essential should the company choose to appeal those…
…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…
…minimal safety standard, but did in fact “establish both ‘floor’ and ‘ceiling’.” Although it might be said that this preamble was a politically motivated legal opinion about statutory construction and…
…(bb) an approved method of using the drug. The MMA also added almost identical counterclaim provisions at FDC Act §505(j)(5)(C)(ii)(I) applicable to ANDA sponsors. Both counterclaim provisions refer to FDC…
…yet been approved), follows almost identical Advisory Opinion Requests filed in January 2005 by GlaxoSmithKline (Docket No. 2005A-0015), in August 2006 by AstraZeneca (Docket No. 2006A-0318), and in June 2007…
…of the historical background that spurred Congressional action here, including national security risks highlighted by U.S. Departments of Defense (DoD) and Commerce actions against several specific Chinese biotechnology companies. An…
…dramatic effect on import alerts. FDA issued 28 quality-related import alerts in 2022, and most of those 28 alerts were for hand sanitizers that contained impurities or had other defects….
…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…
…by potential generic competitors, but the FDA mayor may not decide to give final approval to competing generics and it mayor may not decide to give final approval in a…
…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…
…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…
…applicant” to mean: an applicant that, on the first day on which a substantially complete application containing a [Paragraph IV certification] is submitted for approval of a drug, submits a…
…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…
…(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”…