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.
June 1, 2022
Act II: The Senate Unveils Its Draft
May 10, 2022
And So It Begins: House Energy and Commerce Leaders Unveil FDA User Fees Legislative Package
February 8, 2022
Europe - Between The EU Clinical Trials Regulation And The UK Guideline On Clinical Trials
Tamra Moore to Speak on AI for Health Equity Virtual Symposium 2022
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