Maarika Kimbrell

Morgan Lewis

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Life Sciences

Latest Posts › Regulatory Reform

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FDA’s New Priority Voucher Program for Drug Developers Ties Incentives to Defined National Interests

The US Food and Drug Administration recently announced the launch of a regulatory incentive program pilot program, the Commissioner’s National Priority Voucher Program (CNPVP), designed to reward drug and biologic sponsors...more

8/12/2025 / Biologics , Food and Drug Administration (FDA) , Investigational New Drug Application (IND) , Life Sciences , Manufacturers , Pharmaceutical Industry , Public Health , Regulatory Reform , Research and Development

Navigating FDA’s Evolving Approach to Guidance Publication for Medical Products

Guidance development and publication from the Food and Drug Administration (FDA) has long been considered an essential element of medical product development, approval, and regulation. While temporary pauses in guidance...more

6/10/2025 / Coronavirus/COVID-19 , Drug Pricing , Executive Orders , Food and Drug Administration (FDA) , Generic Drugs , Medical Devices , New Guidance , Public Health , Regulatory Reform , Rulemaking Process

Conditional Approval Proposals for FDA: Current Context and Potential Ramifications

Drug approval is unequivocally the linchpin to any drug development effort and, given the role of the US market in the global marketplace, the drug approval standard employed by FDA remains a perennial focus of stakeholders...more

5/1/2025 / Clinical Trials , Drug Pricing , Food and Drug Administration (FDA) , New Regulations , Patient Access , Pharmaceutical Industry , Prescription Drugs , Public Health , Regulatory Reform

FDA Regulatory Uncertainty Calls for Strategic Decision-Making by Drug Developers

The recent reductions in the US Food and Drug Administration’s workforce are poised to have a substantial impact on drug and biologic development programs. This LawFlash discusses strategies to optimize interactions with the...more

4/7/2025 / Biotechnology , Clinical Trials , Drug Pricing , Food and Drug Administration (FDA) , New Guidance , Pharmaceutical Industry , Prescription Drugs , Regulatory Oversight , Regulatory Reform , Regulatory Requirements

FDA’s Recent Guidance on Accelerated Approval and Implications for Rare Diseases

In honor of Rare Disease Day on February 28, 2025, we will publish a series of posts throughout the month on As Prescribed and Health Law Scan, focusing on issues impacting the rare disease community....more

3/3/2025 / Federal Food Drug and Cosmetic Act (FFDCA) , Food and Drug Administration (FDA) , Health Care Providers , Life Sciences , New Guidance , Patient Access , Pharmaceutical Industry , Regulatory Reform , Regulatory Requirements

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