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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