Clinical Research Solutions
Key Steps to Creating a Successful Market Access Strategy
Understanding Health Technology Assessment (HTA) authorities’ requirements throughout the product development phase is crucial for a successful market access strategy and planning. This will increase...
Clinical Research Solutions
Navigating a Shifting Regulatory Landscape: The Impact of FDA Layoffs on Medical Device Developers
On Thursday, March 27, 2025, HHS announced that they would be conducting a reduction in force impacting nearly 3,500 full time FDA employees – nearly 20% of the Agency’s entire workforce. This comes...
Clinical Research Solutions
Scientific Data Works: Using Science to Navigate the Global Regulatory Maze
You’re developing an FDA – and/or EMA-regulated drug, biologic, or medical device. Throughout the drug development process, your goal is to get to the next regulatory milestone in the most...
Clinical Research Solutions
FAQs: Model Informed Drug Development (MIDD) & Modeling and Simulation (M&S)
Question & Answer with Sander Vinks, PhD, PharmD, FCP, Regarding MIDD and M&S In the ever-evolving landscape of drug development, efficiency, precision, and regulatory success are paramount....
Clinical Research Solutions
Navigating the New EU Health Technology Assessment Regulation (HTAR): Are You Ready?
The HTAR in the EU has come into force – what Health Technology Developers (HTDs) need to know Getting your health technology product to the market is complex and usually consists of several steps...
Clinical Research Solutions
The End of the FDA’s Rare Pediatric Disease Priority Review Voucher Program
What’s Next for Rare Disease Innovation? For children suffering from rare and often life-threatening diseases, access to new and effective treatments can mean the difference between life and death....
Clinical Research Solutions
Leveraging Single-Arm Trials for Regulatory Approval: Insights from EMA's Reflection Paper
The pharmaceutical industry has shown a growing interest in single-arm trials due to their potential to expedite drug development. However, several challenges and concerns remain. The European...
Clinical Research Solutions
Drug Development: The Key to Success from Concept to US Commercialization
Congratulations! You have a lead candidate formulation for your new drug. You might be thinking to yourself, “okay, now what?” We all know the science and effort to get to this stage is significant....
Clinical Research Solutions
European Pharma Regulations: 2024 Review and 2025 Trends to Watch
Gaining a Competitive Edge: 2024's European Pharma Regulatory Review & Trends to Look for in 2025 and Beyond As the pharmaceutical landscape in Europe evolves rapidly, regulatory frameworks are...
Clinical Research Solutions
Nonclinical Drug Development: FDA Recommendations for Confirming an Ames Positive Finding
On November 27,2024, FDA released a draft guidance intended “to inform industry and the review staff in the Center for Drug Evaluation and Research (CDER) on how CDER views positive findings in the...