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Quit Monkeying Around: FDA Offers Faster Approval Times in Bid to Phase Out Animal Testing

On April 10, 2025, the US Food and Drug Administration (FDA) announced its intent to phase out the use of animal testing in the development of certain drugs and biologics. To help bring this “paradigm shift in drug...more

Will It (Puff, Puff) Pass? Cannabis Reform Under the Trump Administration

The Trump administration’s approach to cannabis reform will significantly impact the industry. As the proposed rulemaking to reschedule cannabis unfolds and nominees to critical agencies are confirmed, it is crucial for...more

Preparing for 2025: Key Trends in FDA Guidance Agendas

In January 2025, various US Food and Drug Administration (FDA) centers and offices published their guidance agendas for the 2025 calendar year (CY). These agendas provide valuable insights into FDA’s regulatory priorities,...more

FDA’s Fresh Take on Use of “Healthy” in Food Labeling

On December 19, 2024, the US Food and Drug Administration (FDA) issued a new final rule titled “Food Labeling: Nutrient Content Claims; Definition of Term ‘Healthy.’” The rule revises regulations that govern when food...more

CDRH Looks Ahead With FY 2025 Proposed Guidance Agenda

On October 10, 2024, the US Food and Drug Administration’s (FDA) Center for Devices and Radiological Health (CDRH) announced its agenda of proposed guidance documents to be published or developed in the 2025 fiscal year (FY)....more

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