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…As FDA regulatory practitioners who have worked with multiple companies trying to introduce COVID-19 tests, we have witnessed first-hand both the challenges faced by companies seeking to bring new tests…
…be required to comply with the regulation. Although the rule addresses many aspects of the Medicaid Rebate Program, CMS has solicited comments only on the AMP and Federal Upper Limit…
…that his first priority is defeating COVID-19, and his administration will, to a large extent, be dependent on the cooperation of pharmaceutical companies in order to achieve that goal. His…
…In order to demonstrate “willful blindness,” DEA must “prove that the pharmacist had a subjective belief that there was a high probability that a fact existed and she took deliberate…
…514.235(b) permit a direct appeal to an appellate court within 60 days after the entry of a relevant FDA order.) In ECR Pharmaceuticals v. Margaret Hamburg (Case No. 11-1120), which…
…Enroflox™ 100, a generic version of Bayer’s fluroquinolone animal drug Baytril® 100 (enrofloxacin) Injectable Solution, has paid off. FDA, following an April 12, 2013 Order from the U.S. District Court…
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…
…suspicious order reporting and monitoring. DEA stated that, short of providing arbitrary thresholds to distributors, “it cannot provide more specific suspicious orders guidance because the variables that indicate a suspicious…
…us quickly noticing. That recently happened when Prometheus Laboratories Inc. (“Prometheus”) filed a Complaint and a Motion for Temporary Restraining Order and/or Preliminary Injunction in the U.S. District Court for…
…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…
…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. …
…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…
…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,…
…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…