Maarika Kimbrell

Morgan Lewis

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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

FDA Extends Scrutiny Over Color Additives Beyond Food to Drug Products

FDA’s recent focus on potentially harmful color additives in food products has expanded to the pharmaceutical sector. In May 2025, FDA issued a draft guidance titled Replacing Color Additives in Approved or Marketed Drug...more

6/6/2025 / Comment Period , Draft Guidance , Food and Drug Administration (FDA) , Food Safety , New Guidance , Over The Counter Drugs (OTC) , Pharmaceutical Industry , Prescription Drugs , Regulatory Oversight , Regulatory Requirements

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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