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USFDA Guidance: Integrating Patient-Focused Development, Expanded Access, and Clinical Data Specifications in the Evolving FDA Framework
The U.S. Food and Drug Administration (FDA) continues to refine its regulatory guidance structure to ensure that patient experience, ethical access pathways, and robust data science converge effectively in modern drug development. Three cornerstone guidance documents released through 2024–2025 exemplify this integration — focusing on patient-focused drug development, expanded access to investigational drugs, and technical specifications for clinical trial data submissions. 1.
Sharan Murugan
1 day ago3 min read
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USFDA Guidance: Q&A-Charging for Investigational Drugs Under an IND - What You Need to Know
Earlier this week (14 February, 2024) the the U.S. Food and Drug Administration (FDA)Â released guidance "Charging for Investigational...
Sharan Murugan
Feb 17, 20241 min read
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USFDA Guidance: IRB Review of Individual Patient Expanded Access Submissions & Peptide Drug Products
Earlier today (11 September 2023), The U.S. Food and Drug Administration (FDA) Center for Drug Evaluation and Research, Center for...
Sharan Murugan
Sep 11, 20232 min read
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USFDA Guidance: Expanded Access to IND Q&A and Assessing User Fees under OMUFA
Earlier Today (1-November-2022), the U.S. Food and Drug Administration issued a revised draft guidance for the industry, “Expanded Access...
Sharan Murugan
Nov 1, 20221 min read
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