Innovation, Technology, and IP News

Written by:Matthew Ruth & Philip M. Nelson Going forward, medical device approval will require the device maker to provide... Read More »

In the world of pharmaceuticals, the Abbreviated New Drug Application (ANDA) process plays a critical role in the approval and market... Read More »

Written by: Raina Patel The use of artificial intelligence (AI) in healthcare has been growing rapidly in recent years, and AI-enabled ... Read More »

Written by: Alistair J. McIntyre The FDA recently announced release of final transition guidance documents for... Read More »

Written by: Paige L. Cappelli The FDA recently announced that it is seeking a budget of $7.2 Billion for 2024, part of... Read More »

Written by: Nima Zargari, Ph.D. On February 24, 2023, in Jazz Pharms., Inc., v. Avadel CNS Pharms., LLC, the U.S. Court of... Read More »

Written by: Albert J. Sueiras Cochlear implant developer Advanced Bionics LLC will pay about $12 million to resolve... Read More »

EndoStim announced on October 25th that the FDA granted a breakthrough device designation for the company’s implantable... Read More »

In late August, we published our third annual ANDA Litigation Intelligence Report, covering important statistics and evaluating all stakeholders in ... Read More »

On September 28, 2022 the FDA announced a collaboration with the Veterans Health Administration (VHA), in particular the VA Ventures ... Read More »

On September 23, 2022, the Food and Drug Administration (FDA) published a draft guidance aimed to protect children who participate in clinical... Read More »

The FDA has published new web pages about Monkeypox and medical devices. The new web page, titled Monkeypox and Medical Devices, includes ... Read More »

Less than two months ago, Curevac filed a lawsuit in the German Regional Court in Düsseldorf against BioNTech over patent... Read More »

  Small molecule drugs have been the norm for much of medicine’s history. Only in the past decade has there been a rise ... Read More »

On May 5, 2022, the FDA’s Center for Devices and Radiological Health (CDRH) issued draft guidance regarding the FDA’s... Read More »

On April 08, 2022, the Food and Drug Administration (FDA) published a draft cybersecurity guidance document for medical devices... Read More »

Medtronic recently announced that it received clearance from the FDA and CE Mark approval for its LINQ II insertable cardiac monitor (ICM). The announcement notes... Read More »

The U.S. Food and Drug Administration (FDA) has issued two new guidance documents related respectively to an “abbreviated” and a “special”... Read More »

Last year, in a lengthy split decision, a Fed. Cir. panel affirmed the district court’s ruling that four “add-on” patents that Acorda owned were... Read More »

On March 7, 2019, the U.S. Food and Drug Administration (FDA) and the U.S. Food Safety and Inspection Service (FSIS) announced a formal agreement, in the form of a... Read More »