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…an ongoing effort to address drug shortages in the United States. Recall that President Obama, in 2011, issued an Executive Order to address the issue. We blogged on that here. …
…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…
By Jennifer M. Thomas – On October 1, 2015, the U.S. District Court for the District of New Jersey unsealed its opinion in United States v. Bayer Corp., No. 07-cv-00001…
…(PMTA) pathway. The FDA press release describes marketing orders for eight Swedish Match North America, Inc. snus smokeless tobacco products marketed under the “General” brand name. The PMTAs were apparently…
…Federal Circuit ruled in a highly fractured July 21, 2015 decision (Amgen Inc. v. Sandoz Inc., 794 F.3d 1347 (Fed. Cir. 2015)) that aBLA licensure is required before an “operative…
…and the owners, Mr. and Mrs. Resnick filed a brief in the D.C. Circuit. On the same date, Matthew Tupper (President of POM) filed his brief. Because each brief adopted…
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…
…. . . . FDA considers it necessary to subject all such devices to part 803 in the interim, in order to protect the public health by ensuring that there…
…feature of the bill. The draft also requires that all compounding pharmacies comply with both USP <795> (non-sterile compounding) and USP <797> (sterile compounding). The draft proposal emphasizes sharing of…
…U.S.C. § 156(c)(4)) that “in no event shall more than one patent be extended . . . for the same regulatory review period for any product.” The U.S. Patent and…
…See, e.g., Warner-Lambert Co. v. Shalala, 202 F.3d 326 (D.C. Cir. 2000). Indeed, Purdue Pharma L.P. (“Purdue”) recently submitted a Petition for Reconsideration (Docket No. FDA-2012-P-0939) after FDA denied without…
…pursuant to Executive Order (EO) 12866 issued by President Clinton and its predecessor EO 12291 issued by President Reagan. The purpose of that review has been explained by OMB as…
…U.S. Supreme Court’s decision in Ewing v. Mytinger & Casselberry, Inc., 339 U.S. 594 (1950), and is therefore not ripe. The D.C. Circuit affirmed the district court decision, explaining that…
…ones. . . .” (see here and here) GAO Report In its Report, the GAO confirmed much of what on-lookers, industry, and FDA already knew or suspected. The Report cites…
…Modernization Act (“FSMA”). The fees kick in on October 1, 2011. The hourly fee rate is $224 ($335 if foreign travel is required). FDA can be expected to collect fees…