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USFDA Guidance: Safety Assessment of Genome Editing in Human Gene Therapy Products Using NGS and Expanded Access to Investigational Drugs for Treatment Use-Q&A
The regulatory landscape for advanced therapies and patient access in the United States continues to evolve, with the FDA issuing updated guidances in April 2026 that address both cutting-edge genome editing safety and patient access to investigational treatments . Together, these guidances highlight the balance between innovation, safety evaluation, and ethical access to therapies across the product lifecycle. The guidance Safety Assessment of Genome Editing in Human Gene
Sharan Murugan
Apr 203 min read
USFDA Guidance: Safety Reporting for Investigational Drugs and Devices & Requirements and Safety Assessment for IND and Bioavailability/Bioequivalence Studies
Safety reporting is one of the most critical safeguards in clinical trials involving investigational drugs and medical devices. To ensure that safety information is collected, evaluated, and communicated effectively, the U.S. Food and Drug Administration (FDA) has issued two complementary guidance documents: Investigator Responsibilities — Safety Reporting for Investigational Drugs and Devices (December 2025), and Sponsor Responsibilities — Safety Reporting Requirements and
Sharan Murugan
Dec 20, 20253 min read
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) released guidance "Charging for Investigational...
Sharan Murugan
Feb 17, 20241 min read