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…rejected in an NAD compliance review. Under NAD procedures, such cases ordinarily are automatically referred to the FTC for review. Whether new studies that meet the legal test for substantiation…
…component, part, or accessory of a tobacco product (except for raw materials other than tobacco used in manufacturing a component, part, or accessory of a tobacco product).” Option 2 of…
…the biosimilar and the reference product be compared through use of a “meaningful fingerprint-like analysis algorithm.” FDA expects that this comparative analytical characterization will lead sponsors to one of four…
…(H.R. 6160) – that is intended to direct companies “to invest in research and production to formulate tamper resistant drugs in order to compete with drugs of a similar nature…
…that the FTC attacked. The ALJ’s order would merely bar POM from making certain claims unless POM possesses competent and reliable scientific evidence to support the claim. As clarified in…
…has moved forward for a decision on the merits. In a Motion for Summary Judgment sanofi filed earlier this week, the company continues to allege that that FDA’s approval of…
…calls received for such substances in all of 2010. In addition, the U.S. Customs and Border Patrol has encountered at least 96 shipments of synthetic cathinones at one border; most…
…seeking review of an FTC cease and desist order. The FTC Order, issued in 2009, concluded that DCO had made advertising claims that were not substantiated. The Court’s decision concerns…
…483. In response, FDA filed a complaint in August 2010 seeking to permanently enjoin Regenerative from using stem cells to treat patients without approval. The Court eventually issued an order…
By Karla L. Palmer & Larry K. Houck – Consistent with its November 24, 2010 Notice of Intent, the Drug Enforcement Administration (“DEA”) published its Final Order temporarily placing five…
…civil inquiry and demand from the [Federal Trade Commission (“FTC”)]. The FTC requested documents and other information relating to requests by generic companies to purchase our patented REVLIMID® and THALOMID®…
By Kurt R. Karst – Last week, the Federal Trade Commission (“FTC”) announced that the Commission’s Bureau of Competition (“Bureau”) sent letters (here, here, and here) to Sanofi-Aventis U.S. LLC,…
…will be of interest to the Hatch-Waxman community. The case, like so many Hatch-Waxman cases, is complicated. It involves an ANDA for a generic version of SOLARAZE (diclofenac sodium) Gel,…
…a company’s employees could disclose otherwise privileged documents, or make statements on behalf of the company without the company’s knowledge. In In re Amgen, Inc., No. 10-MC-0249(SLT) (E.D.N.Y. Apr. 6,…
…which Judge Hilton ordered the Patent and Trademark Office (“PTO”) to consider timely filed The Medicines Company’s (“MDCO’s”) PTE application for U.S. Patent No. 5,196,404 covering ANGIOMAX (bivalirudin) under a…