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Landmark CAFC Cases in Patent Law: Shaping the Future of Innovation

In the ever-evolving landscape of patent law, the Court of Appeals for the Federal Circuit (CAFC) has played a pivotal role in shaping the rules and precedents governing intellectual...

FDA Releases Draft Guidances on 510(k) Submissions

Written by: Paige L. Cappelli On September 6, 2023, the U.S. Food & Drug Administration (FDA) released three draft guidance documents to provide updated...

IPR Decision Based on a Barely Mentioned Typo Violated the APA Notice Requirement

Written by:Brianne M. Kingery & Daniel Kiang APPLE INC. v. COREPHOTONICS, LTD. Before Stoll, Linn, and Stark. Appeal from the Patent Trial and Appeal Board. Summary: An IPR...

Feed tagged as "fda":
Written by: Paige L. Cappelli On September 6, 2023, the U.S. Food & Drug Administration (FDA) released three draft... Read More »
Written by: Ari Feinstein & Jane Dai, Ph.D. On June 2, 2023, drug manufacturer Shire US Inc. and related entity Shire LLC... Read More »
Written by: Nima Zargari, Ph.D. On August 15, 2023, the Food and Drug Administration (FDA) issued its updated guidance on... Read More »
We are proud to announce that tomorrow marks the release of the fourth edition of our ANDA Litigation Intelligence Report. This year's report... Read More »
Written by: Kenneth O. Aruda, Ph.D. Software is increasingly used as a medical device, transforming the healthcare industry with the... Read More »
In the realm of pharmaceuticals, the approval process for generic and brand-name drugs holds significant importance. The Hatch-Waxman Act, ... Read More »
Written by: Philip M. Nelson Medical Device companies often need the U.S. Food and Drug Administration (FDA) to approve... Read More »
Written by: Joshua C. Loader The U.S. Food and Drug Administration (FDA) recently released draft guidance regarding clinical ... Read More »
British drugmaker GlaxoSmithKline (GSK) has taken American pharmaceutical giant Pfizer to court, alleging a violation of its patent rights ... Read More »
In the world of pharmaceuticals, access to affordable generic drugs is crucial for ensuring cost-effective healthcare solutions. The Drug... Read More »
Written by: Arash Pia The FDA has updated its Medical Device Shortages List to remove Specimen Collection, Laboratory... Read More »
Written by: Zachary B. Messick The FDA implemented the breakthrough device program in 2015.  The program was designed to... Read More »
Written by: Michael R. Christensen On August 22-23, 2023, the FDA will conduct an Advisory Committee... Read More »
Written by: Mark Rubinshtein, Ph.D. Neuralink, the biotechnology company founded by Elon Musk, has received approval from the... Read More »
Written by: Julie Kim On June 5, 2023, GE HealthCare announced the FDA 510(k) clearance of Sonic DL™.  GE... Read More »
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 »
Allen EhrlichAs an expert in medical devices, the FDA needs additional funding to speed up the timeline for approval of new innovative products. Hoping that Congress will approve this budget.
Mar 21, 2023
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