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Earlier this week, the U.S. Senate Health, Education, Labor, and Pensions (“HELP”) Committee released a “Manager’s Amendment” to S. 934, the FDA Reauthorization Act of 2017 (“FDARA”). The 171-page Manager’s…
…during the mark-up session, including provisions concerning over-the-counter hearings aids, requiring risk-based device inspections, restricting drug imports . . . . and, of particular interest to this blogger, provisions creating…
…Cent. Hudson Gas & Elec. Corp. v. Pub. Serv. Comm’n, 447 U.S. 557 (1980)) and finding that pharmaceutical speech qualifies for such protection (see Sorrell v. IMS Health, Inc., 131…
…the form of randomized, controlled human clinical testing (RCTs) to meet the competent and reliable scientific standard. . . . Animal and in vitro studies may provide useful supporting or…
By Kurt R. Karst – Earlier this week, Cody Laboratories, Inc. and Lannett Co., Inc. (collectively “Cody/Lannett”) filed a Complaint and a Motion for Temporary Restraining Order and Preliminary Injunction in…
…In March 2010, the U.S. Court of Appeals for the District of Columbia Circuit ruled in Teva Pharms USA, Inc. v. Sebelius, 595 F.3d 1303 (D.C. Cir. 2010), that Teva…
By Kurt R. Karst – Earlier today, FDA announced that the Agency has taken enforcement action against several manufacturers of unapproved prescription narcotics. The 9 Warning Letters issued by FDA…
…increased, but FDA’s federal funding is dwindling. The effects of this situation are now being felt acutely by the agency and those it serves. . . . We are concerned…
On September 27, 2007, the U.S. House of Representatives Committee on Energy and Commerce passed H.R. 970, the Dextromethorphan Distribution Act of 2007, after a legislative “mark-up” session. Similar legislation…
…are bound by FDA regulation to conform their labels to that of the brand-name drug. . . . However, . . . that issue is not before the Court in…
…orphan drug. FDA’s orphan drug regulations (21 C.F.R. Part 316) define a “clinically superior” drug as “a drug . . . shown to provide a significant therapeutic advantage over and…
In a case involving a highly unusual set of facts for FDA-regulated companies, Leiner Health Products, Inc. (Leiner) is seeking to have a plea agreement approved by a Bankruptcy court. …
…FTC v. Catlin Enterprises, Inc., as examples of the possible consequences of making unsupported claims. FDA and the FTC have requested responses from all the companies within 15 working days….
…to come into compliance. What will ultimately happen to the TA or other IVD legislation is uncertain. Clearly, a new law will not be enacted this year. Given the competing…
…and other agencies. Adrienne R. Lenz joined HP&M as a Senior Medical Device Regulation Expert. Adrienne Lenz provides consulting to medical device and combination product manufacturers. Ms. Lenz assists clients…