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Lauren K. Roth
Insights 13 results
Client Alert
February 16, 2026
FDA Issues Refuse-to-File Letter for mRNA-based Vaccine BLA
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
Client Alert
September 10, 2025
HHS and FDA Declare “Crackdown” on Drug Advertising and Promotion
Client Alert
July 11, 2025
FDA Publishes More Than 200 Complete Response Letters (CRLs) With More to Come
Article · Source: Law360
June 26, 2025
Psychedelic Treatment Regs May Be At A Tipping Point
Client Alert
June 5, 2025
Administrative, Congressional, and State Interest Signal a Potential Breakthrough Moment for Psychedelics
Client Alert
June 4, 2025
FDA Issues Two Guidances For the Device Q-Sub Process
Client Alert
May 9, 2025
New Executive Order Promotes Domestic Production of Critical Medicines