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.
November 18, 2022
GAO Issues Report on Artificial Intelligence in Health Care
May 5, 2022
Lisa Dwyer comments on the House legislation renewing the U.S. FDA’s user fee programs that would undo negative court rulings against the agency and reinstate its policies on orphan drug exclusivity and the designation of contrast agents as drugs
February 10, 2022
Preeya Pinto explains why the Centers for Medicare and Medicaid Services diverged from its statutory authority and past precedents when it proposed that Medicare would only cover Alzheimer’s drugs
August 24, 2021
Arbor Pharmaceuticals to Merge with Azurity Pharmaceuticals