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[Podcast] FDA-Regulated Products Supply Chain Disruptions: Policy Shifts

Navigating the complexities of maintaining a stable supply chain in an ever-changing global environment is a key focus for FDA-regulated companies. As US policy shifts, the topic of global supply chain has only become more...more

FDA Issues New Guidance for Collecting Postmarketing Data on Underrepresented Patient Populations

In a notable step toward more equitable healthcare, the U.S. Food and Drug Administration (FDA) introduced new draft guidance on August 10, Postmarketing Approaches to Obtain Data on Populations Underrepresented in Clinical...more

Artificial Intelligence and Machine Learning in the Development of Drug and Biological Products

On May 10, the U.S. Food and Drug Administration (FDA) published a discussion paper, “Using Artificial Intelligence & Machine Learning in the Development of Drug & Biological Products.” The paper is a collaboration between...more

FDA Announces Impact of Ending COVID-19 Public Health Emergency

On March 13 the FDA officially issued a Federal Register notice to explain how the end of the COVID-19 PHE declaration will impact the Agency’s 72 COVID-related guidance documents currently in effect. The notice comes as the...more

FDA Issues Guidance on Clinical Research with Cannabis

On Jan. 23, the Food and Drug Administration (FDA) finalized industry guidance for clinical research using cannabis and cannabis-derived compounds, Cannabis and Cannabis-Derived Compounds: Quality Considerations for Clinical...more

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