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…Commonwealth from taking any action to implement or enforce the declaration and order. Though down, the Commonwealth was not out. Commonwealth officials went right to work after the district court’s…
…denied Omnicare, Inc.’s motion for summary judgment in the ongoing qui tam case, United States ex rel. Banigan v. Organon USA, Inc., et al. (Case 1:07-cv-12153-RWZ). In their complaint, filed…
…District Court for the District of Columbia issued a 2-page order siding with Teva. Judge Lamberth’s order declared that the delisting of the ‘952 patent was unlawful, ordered FDA to…
On December 11, 2018, the authors of this blog post attended the oral argument in Federal Trade Commission v. Shire ViroPharma, Inc., No. 18-1807 (3d Cir. filed Apr. 12, 2018)….
…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…
…for the District of Columbia’s order in Mylan Laboratories, Inc. v. Leavitt that FDA decide by Wednesday, April 11th whether it will approve any Abbreviated New Drug Applications (“ANDAs”) for…
…advisory committee meeting is warranted. The SIA limits the number of advisory committee meetings FDA must convene per sunscreen TEA and per year. The combination of FDA’s limits on what…
…of the original tentative final order, and thirty-six years after the initial proposed order, the FDA has yet to finalize the Monograph. In the meantime, [OTC] antimicrobial drug products containing…
…the FDC Act to require Country-Of-Origin (“COO”) labeling on prescription and Over-The-Counter (“OTC”) drug products. Specifically, the bill would amend FDC Act § 502 so that a prescription drug would…
…complied with all of the applicable requirements under the Executive order and have determined that the preemptive effects of this rule are consistent with Executive Order 13132. In another turn…
…Oregon claimed (as it had several times in the past) that it could not comply with the administrative subpoenas absent a court order; thus it filed a declaratory judgment action…
…2013 petition to FDA. UPDATE: May 9, 2014: The following Minute Order was entered: MINUTE ORDER denying plaintiffs’ motion for a temporary restraining order. For the reasons stated on the…
…a Memorandum Opinion and Order granting Hospira’s Motion for Temporary Restraining Order. In doing so, Judge Hazel said that Hospira demonstrated that the company is likely to succeed on the…
…over the applicability and correct interpretation of various provisions of the the Biologics Price Competition and Innovation Act of 2009 (“BPCIA”). The dispute comes in the context of Sandoz Inc.’s…
…Basic Research. According to Basic Research’s 2009 compliant, FTC threatened to bring contempt proceedings against the company under a prior consent agreement entered into by FTC and Basic Research in…