By Riette Van Laack – On June 30, as required under the consent decree in the action by the National Resource Defense Council against FDA (see our previous post here), FDA published the amended tentative final monograph for consumer antiseptic rubs, also referred to as consumer rubs, leave …
Hyman, Phelps & McNamara, P.C., the nation’s largest boutique food and drug regulatory law firm, seeks two attorneys to help with our fast-growing and robust practice. The ideal candidate for one position is an attorney with substantive expertise in medical device regulation. The other attorney is …
By Andrew J. Hull & Mark I. Schwartz On Tuesday, the U.S. Court of Appeals for the Federal Circuit affirmed a preliminary injunction against Apotex Inc. and Apotex Corp. (collectively, “Apotex”) related to Apotex’s biosimilar version of Amgen Inc. and Amgen Manufacturing Limited’s (collectively, “Amgen’s”) NEULASTA …
By Allyson B. Mullen, Jeff N. Gibbs, McKenzie E. Cato* – Technological advances have resulted in Next Generation Sequencing (NGS) being used more and more frequently by diagnostic laboratories. NGS in vitro diagnostics (IVDs) present a new set of regulatory and technical challenges for FDA and …
Hyman, Phelps & McNamara, P.C., the nation’s largest boutique food and drug regulatory law firm, seeks two attorneys to help with our fast-growing and robust practice. The ideal candidate for one position is an attorney with substantive expertise in medical device regulation. The other attorney is …
By Jennifer M. Thomas & John R. Fleder – On July 6, 2016, the Eighth Circuit upheld a district court ruling in United States v. DeCoster that imposed three-month prison sentences and $100,000 fines on Austin “Jack” and Peter Decoster, the owner and chief operating officer, …
By Kurt R. Karst – We like hunting down orphan drug clinical superiority precedents. And although it’s been said that “the thrill is in the chase, never in the capture” (by a Doctor Who character at least), we enjoy the capture just as much as the …
McKenzie E. Cato* and Allyson B. Mullen Many device companies struggle to ensure that the patients enrolled in their clinical studies are representative of the sex, age, race, and ethnic make-up of the U.S. population. In part, this task is difficult because device clinical studies are …
