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perspectives

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

perspectives

January 9th, 2025

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

perspectives

January 2nd, 2025

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

perspectives

December 17th, 2024

Oncology Drug Development: Webinar Learnings on the Use of Expedited Pathways and Oncology Center of Excellence Programs

perspectives

December 11th, 2024

Why Emerging Biotech Companies are Increasingly Turning to Specialized Data CROs

regulatory intelligence

December 4th, 2024

FDA Issues Detailed Guidance on Development of Gene Therapy Products

news

December 4th, 2024

AI in Pharma and Innovative Leadership Were on Display at the Biennial MMS Scientific Symposium

perspectives

November 26th, 2024

Finding GRASEland: Navigating the New Regulatory Path for Grandfathered OTC Drugs 

perspectives

November 21st, 2024

Essential Nonclinical Strategies for Cell and Gene Therapy (CGT) Success

news

November 19th, 2024

MMS Recognized as a Top Workplace by Detroit Free Press and USA Today Network for the Fourth Consecutive Year