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D. Kyle Sampson
Insights 29 results
Client Alert
May 12, 2026
FDA’s New Oversight Tool: One-Day Inspectional Assessments
Client Alert
April 20, 2026
FDA Reminds Sponsors and Researchers to Disclose Clinical Trial Results to ClinicalTrials.gov
Client Alert
March 10, 2026
FDA Issues Draft Guidance on Responding to FDA Form 483 Observations Following Drug Inspections
Client Alert
February 16, 2026
FDA Issues Refuse-to-File Letter for mRNA-based Vaccine BLA
Client Alert
February 3, 2026
The QMSR Goes Live and FDA Implements a New Medical Device Inspection Technique
Client Alert
January 9, 2026
FDA Updates General Wellness and Clinical Decision Support Guidance Documents
Client Alert
December 19, 2025
FDA Issues New Guidance for Enhancing Participation in Drug Clinical Trials
Article · Source: Thomson Reuters Westlaw Today
November 20, 2025
FDA Leaders Propose New “Plausible Mechanism Pathway” for Development and Approval of Drugs and Biologics
Client Alert
November 19, 2025
FDA Leaders Propose New “Plausible Mechanism Pathway” for Development and Approval of Drugs and Biologics
Client Alert
September 11, 2025
Advancing Novel Treatments for Rare Diseases: FDA Unveils and Previews New Efforts to Assess Therapies for Very Small Patient Populations
Article · Source: Law360
August 21, 2025
Breaking Down The Proposed Hemp Bill
Client Alert
August 4, 2025
Congressional Crack Down on Hemp Loophole? Significant Changes Loom for Hemp Industry