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…U.S. Constitution prohibits the government from relying upon a company press release and related communications alleged to be part of the wire fraud and misbranding that the defendant reportedly committed. …
By William T. Koustas – Regenerative Sciences, Inc. (“Regenerative”) filed a complaint in the U.S. District Court for the District of Columbia against FDA on June 22nd in order to prevent…
…are three types of Premarket Notification 510(k)s: Traditional, Special, and Abbreviated. The most common type is the Traditional 510(k), therefore this section summarizes the timeline of the FDA review process…
By Kurt R. Karst – Earlier today, The Medicines Company (“MDCO”) announced that the company filed a new Administrative Procedure Act (“APA”) lawsuit in the U.S. District Court for the…
…in combination with” the other products sold by the company. Id. at 18-19. For those reasons and others, the Commission denied the Respondents’ appeal and issued a final Order requiring…
…various products over the years. The Federal Trade Commission (“FTC”) is all-too-familiar with Mr. Trudeau and his promotional tactics: since 1998, Trudeau has entered into several Orders with the Agency…
…a healthcare reform bill has cleared the HELP Committee, but the Finance Committee has yet to complete legislation. If and when the Senate passes a bill, differences from the House…
…For example, in 1990, 62 dosage forms were listed, and in 1995, 67 dosage forms were listed). In order for FDA to approve an ANDA (except when approved pursuant to…
…drug product must be shown to be BE to the RLD covered under an approved NDA in order to obtain an AB rating in the OB.” Translated: “The Food and…
…commercial funding, ACCME is now requesting comments on two proposals that create two new designations and review processes for providers of CME programs – the “Commercial Support-Free™ Accredited CME” and…
…statutory language, the judge in Minnesota overseeing multi-district device litigation granted the plaintiffs’ motion to amend their complaint to comply with the Court’s recent ruling in Wyeth v. Levine. The…
…provisions that may have a substantial impact on drug and device companies. First, it mandates disclosure of “gifts and other transfers of value made by drug and device companies to…
…off-label marketing practices of a company. By John R. Fleder UPDATE: On September 8, 2008, Judge Merryday issued an order adopting the Magistrate’s report and recommendation, and dismissing the case….
…quick review of the options available to companies to request user fee waivers and reductions seems in order. Under PDUFA, FDA collects three types of user fees for a drug…
…180-day exclusivity. Judge Lamberth’s order declares that the delisting of the ‘952 patent was unlawful, orders FDA to relist the patent in the Orange Book and restore Teva’s Paragraph IV…