Perspectives
perspectives
January 21st, 2025
REMS Modifications and Revisions: A Retrospective from the Past 12 Months
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
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
perspectives
November 12th, 2024
REMS Logic Modeling: Applying FDA Guidance from November 2024 CDER Webinar
perspectives
November 6th, 2024
How to Successfully Manage Rescue Studies and Turn Around Clinical Trials Facing Failure
perspectives
October 29th, 2024
Why Outsourcing QC of Regulatory and Medical Writing Documents is a Competitive Advantage for Large Pharma Companies
perspectives
October 22nd, 2024
Choosing the Right Clinical Trial Design: A Crucial Step in Protocol Development
perspectives
October 15th, 2024
Putting the Action in Diversity Action Plans and the Real-Time Data Visualization Technology Needed to Ensure It Happens