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FDA Issues Overdue Draft Guidance on Clinical Trial Diversity Action Plans

Yesterday, the U.S. Food and Drug Administration (FDA) released its long-awaited draft guidance on Diversity Action Plans to Improve Enrollment of Participants from Underrepresented Populations in Clinical Studies. This draft guidance replaces the agency’s similarly-titled April 2022 draft guidance and has been issued to satisfy a requirement under the Food and Drug Omnibus Reform Act…

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Form FDA 483 Response Best Practices Announced by the FDA

In Draft Guidance published this week by the U.S. Food and Drug Administration (FDA), Guidance for Industry – Processes and Practices Applicable to Bioresearch Monitoring Inspections, the Agency provides some wisdom on best practices for responding to Form FDA 483s, albeit in the context of its Bioresearch Monitoring (BIMO) program…

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Designating a Platform Technology: FDA’s Long-Awaited Draft Guidance

In newly released Draft Guidance from the U.S. Food and Drug Administration (FDA) entitled, Platform Technology Designation Program for Drug Development, the FDA addresses its new designation program for platform technologies, which is intended to bring efficiencies to drug development, manufacturing, and review processes for applications that incorporate designated platform technologies. Read the…

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Common FDA Bioresearch Monitoring Violations: Updates from FY 2022 to Now

The Bioresearch Monitoring (BIMO) Program, operated by the U.S. Food and Drug Administration (FDA), conducts on-site inspections and data audits in order to effectively monitor the compliance of all FDA-regulated research. As a follow up to our June 2022 post, we highlight the most common violations identified in Fiscal Year…

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Psychedelics & Drug Development — Key Considerations for Healthcare Industry and Life Sciences Companies as Congress Seeks to Tap Into Psychedelics’ Therapeutic Potential

Based on recent regulatory changes at the state and local level and the efforts by the federal government and certain foreign agencies, investors, clinical trial sponsors, life sciences companies, and investigators operating in the psychedelics industry may have reason to be optimistic about the future regulatory landscape for therapeutic psychedelic…

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Seven Tips for Healthcare & Life Sciences Companies Engaging Independent Monitors and Compliance Experts

For a healthcare or life sciences company settling a government enforcement action, the prospect of being subject to an independent monitor, independent review organization (IRO), or other government-mandated compliance expert may become a reality. (We collectively refer to all of these individuals and entities as monitors throughout this update.) Hiring…

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FDA’s Final Q&A Guidance on Risk-Based Monitoring of Clinical Trials Provides Additional Recommendations for Sponsors

The U.S. Food and Drug Administration (FDA) recently finalized its guidance, “A Risk-Based Approach to Monitoring of Clinical Investigations” (the “2023 RBM Guidance”) which follows up on the Agency’s March 2019 draft guidance (the “Draft Guidance”) of the same name and expands on (but does not supersede) the FDA’s August…

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Leveraging Investigator-Initiated Trials in Rare Disease Drug Development

Investigators interested in rare disease treatment development have the opportunity to approach drug and biologic developers to obtain investigational drug supply for trials in which the investigators, typically at academic institutions, act as sponsor-investigators. Similarly, companies open to extending their product development pipelines can look to investigator-initiated trials as a…

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