Medical Regulation > Nova Content
According to IlluminOss Medical, Inc.’s recent press release, the company has successfully obtained the first-ever de novo clearance from the FDA’s... Read More »
Medtronic announced FDA approval and U.S. launch of its Intellis Platform for the management of certain types of chronic intractable pain. According to... Read More »
The U.S. Food and Drug Administration has announced approval of Abbott’s FreeStyle Libre flash glucose monitoring system for certain diabetes patients. ... Read More »
The FDA may begin certifying the laboratories that produce lab-developed tests (“LDTs”) instead of drafting regulatory rules to cover the tests... Read More »
The FDA recently issued a draft guidance document intended to “to ensure that least burdensome principles are implemented for all device-related applications... Read More »
Akili Interactive recently announced results of a trial on the company’s digital medicine product, AKL-T01. According to FierceBiotech, Akili plans to... Read More »
The U.S. Food and Drug Administration (FDA) Commissioner Scott Gottlieb recently announced that the agency plans to publish a draft guidance outlining a voluntary... Read More »
On October 24, 2017, the FDA announced new steps that it is taking to promote beneficial medical device innovation.
First, the FDA completed a first qualification ... Read More »
The U.S. Food and Drug Administration released finalized guidance regarding 3D printing in medical devices. The guidance document, which issued on December 5... Read More »
In Bayer v. Watson, the panel throws out Bayer’s patent to its Staxyn erectile dysfunction drug as being obvious, noting that the district court focused too... Read More »
Written by Robert J. Hilton, Ph.D. and Jing Liu, Ph.D.
On September 14, 2017, the U.S. Food and Drug Administration (FDA) granted accelerated approval of Aliqopa... Read More »
Written by Scott Siera, Ph.D. and Eric Furman, Ph.D.
Seven years after Mylotarg® (gemtuzumab ozogamicin) was voluntarily withdrawn from the market, the U.S... Read More »
On Tuesday, a Delaware district court judge ruled that a group of Mallinckrodt patents failed the Alice/(mostly)Mayo test as claiming a natural phenomenon. The... Read More »
Written by Daniel K. Yarbrough, Ph.D. and Brenden S. Gingrich, Ph.D.
On August 1, 2017, the U.S. Food and Drug Administration released its draft guidance titled... Read More »
Written by Jane Xia and Jing Liu, Ph.D.
MILLENNIUM PHARMACEUTICALS, INC. v. SANDOZ INC
(Fed. Cir. July 17, 2017) (NEWMAN, Mayer, O’Malley)
This case ... Read More »
Written by Marc Chatenay-Lapointe, Ph.D. and Jason Jardine
On July 13, 2017, the U.S. Food and Drug Administration approved Tremfya (guselkumab), a biologic... Read More »
Written by Peter E. Heuser, Schwabe, Williamson & Wyatt, P.C.
The Circuit issued only one precedential patent case this week, reversing a determination of... Read More »
Written by Caleb A. Bates, Ph.D. and Agnes Juang, Ph.D.
On June 19, 2017, the U.S. Food and Drug Administration approved the use of the fluoroquinolone... Read More »
Written by Robert J. Hilton, Ph.D. and Jason J. Jardine
On May 24, 2017, the Food and Drug Administration (FDA) approved the final label for Syndros™... Read More »
Written by Jane Xia and Michael L. Fuller
The U.S. Food and Drug Administration (FDA) recently approved Keytruda (pembrolizumab) for treatment of patients whose... Read More »