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Lisa M. Dwyer
Insights 30 results
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
August 4, 2025
Congressional Crack Down on Hemp Loophole? Significant Changes Loom for Hemp Industry
Client Alert
July 11, 2025
FDA Publishes More Than 200 Complete Response Letters (CRLs) With More to Come
Article · Source: Law360
June 12, 2025
5 Open Questions About FDA's AI-Assisted Review Plans
Client Alert
June 5, 2025
Administrative, Congressional, and State Interest Signal a Potential Breakthrough Moment for Psychedelics
Client Alert
May 19, 2025
FDA Announces Completion of AI-Assisted Scientific Review Pilot and Deployment of Agency-Wide AI-Assisted Review
Article · Source: Journal of Health Care Compliance
May 1, 2025
FDA Releases Draft Guidance on Submission Recommendations for AI-Enabled Device Software Functions
Client Alert
April 4, 2025
FDA's LDT Rule Struck Down by Court: FDA Has Lost the Battle, But Is the War Over?
Client Alert
January 13, 2025
FDA Finalizes Guidance on Scientific Information on Unapproved Uses (SIUU)
Client Alert
January 10, 2025
FDA Releases Draft Guidance on Submission Recommendations for AI-Enabled Device Software Functions
Client Alert
January 6, 2025
FDA Issues Draft Guidance on Accelerated Approval Focused on How the Agency Will Implement New Authorities