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March 19th, 2025

MMS REMS-focused Technology bolsters Full-Service REMS Solutions

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April 30th, 2025

Advancing Clinical Development with Innovative Trial Design and Regulatory Strategies

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March 6th, 2025

Overview of FDA Guidance for Industry on Assessment of Ovarian Toxicity in Premenopausal Adults During Development for Oncologic Products

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March 25th, 2025

Overcoming NDA/BLA Submission Challenges: Practical Strategies for Success

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February 13th, 2025

Helping European Drug Development Companies Succeed in the US Market

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February 12th, 2025

MMS Acquires Exploristics and KerusCloud Simulation Platform to Expand Biostatistics and Data Science Capabilities as a Global Data-Focused CRO

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January 30th, 2025

Post-PDUFA VII Updates: FDA Meetings Public Workshop & Lessons Learned

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January 21st, 2025

REMS Modifications and Revisions: A Retrospective from the Past 12 Months

regulatory intelligence

January 17th, 2025

The FDA’s AI Guidance and its Seven Steps into the Future of Drug Development

regulatory intelligence

January 17th, 2025

New FDA Protocol Deviation Guidance:  Planning for the Things That Don’t Go According to Plan

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January 9th, 2025

How to Create Efficiencies When Creating Simultaneous NDA and MAA Submissions for the FDA and EMA

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January 2nd, 2025

Informed Consent in Clinical Research: Understanding its Significance and Sponsor Obligations