Innovative Drug, Biologic, and Device Development
Regulatory laws and policies create incentives for specific innovation with drugs and biological products, medical devices, combinations, and advanced therapy medicinal products (ATMP) such as cell or gene therapy (CGT) and tissue-based products (HCT/P). The incentives take different forms, such as streamlined procedures; tax credits, fee waivers, or other financial benefits; and marketplace rewards such as exclusivity, patent term extension, and priority review vouchers. A common characteristic of targeted products is to diagnose, prevent, or treat “unmet medical needs” of patients.
King & Spalding works with product researchers, sponsors, and investors to navigate marketing requirements and strategies, as well as the details and intersections of rules governing orphan (rare disease), pediatric, breakthrough, modern technology, and other novel therapies. Recognizing that officials in the U.S., EU, and other jurisdictions promote regulatory convergence – yet still operate separate regulatory systems under different laws and policies – we work in tandem across national boundaries, to strategize and advocate in ways to help our clients effectively benefit from incentives in the laws, minimize duplication or divergence during development, and achieve their ultimate objective to bring safe and effective products to market broadly for the benefit of patients.
October 11, 2023
FDA Finalizes Premarket Cybersecurity Guidance for Medical Devices
November 13, 2023
Eva Temkin discusses the unique promotional considerations under accelerated approval and the heightened regulatory risks sponsors face when conveying information about drugs for which clinical benefit has not been established
November 9, 2023
Lisa Dwyer discusses the impact of the FDA’s updated draft guidance on when drug makers can share information with health care providers about research into off-label uses of their products
August 24, 2021
Arbor Pharmaceuticals to Merge with Azurity Pharmaceuticals