Nikita Bhojani

Morgan Lewis

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Latest Posts › Regulatory Reform

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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's Recent Release of a Roadmap to Reduce Animal Testing

The US Food and Drug Administration (FDA) recently announced a strategic roadmap to phase out animal testing requirements for certain drug products, starting with monoclonal antibodies. This shift marks a significant change...more

4/28/2025 / Animal Testing , Biotechnology , Food and Drug Administration (FDA) , Innovative Technology , Life Sciences , Machine Learning , Pharmaceutical Industry , Prescription Drugs , Regulatory Reform , Research and Development

Salt-Shaking it Up: FDA Issues Proposed Rule to Allow Salt Substitutes in Standardized Foods

FDA has consistently pursued its aim of encouraging US consumers to eat less salt. As we have previously written, FDA issued a Voluntary Sodium Reduction guidance in October 2021 to support the reduction of average sodium...more

6/14/2023 / Comment Period , Dietary Guidelines , Food & Drug Regulations , Food and Drug Administration (FDA) , Food Labeling , Food Manufacturers , Nutrition Facts Labels , Proposed Rules , Regulatory Agenda , Regulatory Reform

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