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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
Oct 263 min read
USFDA Guidance: Submitting Patient-Reported Outcome Data, Clinical Trial Datasets & Documentation
Today (06 November, 2023) the U.S. Food and Drug Administration (FDA) Center for Drug Evaluation and Research (CDER) released two final...
Sharan Murugan
Nov 6, 20232 min read
USFDA Guidance: Clinical Outcome Assessments Into Endpoints for Regulatory Decision
Earlier today (o5 April 2023) USFDA's Center for Drug Evaluation and Research, Center for Biologics Evaluation and Research, and Center...
Sharan Murugan
Apr 5, 20231 min read