On January 8-9, 2015, the U.S. Food and Drug Administration (FDA) hosted a workshop to solicit public feedback on its proposed Framework for Regulatory Oversight of Laboratory Developed Tests (LDTs). As background, the FDA...more
The U.S. Patent and Trademark Office (USPTO) today released its latest iteration of guidance—referred to as the "Interim Eligibility Guidance"—to its examiners. This guidance is aimed at assessing whether an invention claimed...more
On July 31, 2014, the U.S. Food and Drug Administration (FDA) "pre-published" its proposed new plan to regulate laboratory developed tests (LDTs). In letters to the U.S. Senate and the House of Representatives, the FDA...more
In this issue:
- A New Accelerator Takes Digital Health Start-Ups to the Next Level
- The Return of the MedTech IPO Market
- Is There a Deal in Your Future? A Guide to Navigating Antitrust Waters
-...more
Fixed-dose combination drug products are becoming increasingly important in the treatment of patients with diabetes, cardiovascular disease, and infectious disease. Within the last two decades, the U.S. Food and Drug...more
In this issue:
- Best Patent Practices Under the America Invents Act
- CMS Issues Final Rule for Implementing Sunshine Act
- New IP Litigation Team a Boon for Firm's Life Sciences and Technology...more