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…44 44 Thus, it appears that the increase in early notifications to FDA that began as a result of the 2011 Executive Order (Executive Order 13588) has enabled FDA to…
…NDA approval letters for its drug products include an agreement with FDA that the company will not market its product until DEA scheduling is completed and appropriate labeling revisions are…
…regulations. FDA has stated that comments to the draft guidance should be submitted by October 11, 2016 in order to ensure that the Agency considers them before it begins work…
…earlier and in another agency – the Federal Trade Commission. In September 2008, the FTC announced enforcement actions against 11 sellers of bogus cancer cures. One of these 11 companies…
…Order granting the government’s motion for an Order to Show Cause. We will post a more detailed analysis of the Bayer case and its potential effects in the coming days. …
…to R product. The proposed generic product need not have the same formulation design as the R product. In order to adequately compare R and T products, a potential ANDA…
By Kurt R. Karst – Last Friday, ISTA Pharmaceuticals, Inc. (“ISTA”) filed a Complaint and a Motion for a Temporary Restraining Order and a Preliminary Injunction in the U.S. District…
…may be distributed by a company without violating the misbranding provisions of the FDC Act. See, e.g., United States v. Caronia, 703 F.3d 149 (2d Cir. 2012); Op. and Order,…
…first decision dealing with the 180-day notice of commercial marketing provision at PHS Act § 351(l)(8)(A) created by the Biologics Price Competition and Innovation Act of 2009 (“BPCIA”) since the…
…Register. Id. at 50,041 codified at 21 C.F.R. § 1308.50(b). DEA must also transmit the notice of a proposed order to HHS and take into consideration comments from that agency….
…compounded and commercially available substances are “identical,” and, if compounded from bulk substances, whether the compounded version produces a “clinical” difference for the patient (which FDA generally describes the same…
…days (meaning, since President Trump’s inauguration, not coincidentally). Now comes across our computer screen a district court denial of a motion to dismiss filed by a defendant indicted for illegally…
…Consider, for example, the order of NDA approval. FDA’s long-standing position has been that in order for a fixed-dose combination drug to be eligible for 5-year New Chemical Entity (“NCE”)…
…approval requirements. According to the complaint, counsel for the company asked FDA counsel “to identify the statutory or regulatory basis” for the rescission order, to which agency counsel declined to…
…to address non-compliance), and where non-compliance was materially related to food safety requirements (meaning the food is adulterated under FDC Act § 402 or misbranded under § 403(w)). For domestic…