Clinical Research Solutions
Meet the Expert: Clarence Young
Our "Meet the Expert" series introduces you to our team of experts around the world. This "behind the curtain" view will help you get to know who we are on a professional and personal level, and...
Regulatory Sciences
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
FDA Finalizes the Breakthrough Devices Program Guidance and Reinforces Innovative Medical Device Manufacturers that Help to Address Health Inequities
The FDA's Breakthrough Devices Program is intended to expedite the development of innovative technologies for patients with life-threatening or irreversibly debilitating diseases or conditions. The...
Clinical Research Solutions
Single Arm Trials: How to Make the Future Brighter
Randomized clinical trials (RCTs) are widely recognized as the gold standard for clinical and regulatory decision-making. Indeed, RCTs would be required in most cases, in particular when modest...
Clinical Research Solutions
Meet the Expert: Steve Silverman
Expert Consultant, Regulatory Sciences Our "Meet the Expert" series introduces you to our team of experts around the world. This "behind the curtain" view will help you get to know who we are on a...
Clinical Research Solutions
Navigating Expedited Regulatory Pathways in Europe: The Latest Insights and Advancements
Are you truly up to speed on the most effective strategies to expedite the approval process for your innovative product in Europe's evolving regulatory landscape? In the United States (US), the Food...
Clinical Research Solutions
FDA’s Updated Software Guidance
The FDA has recently published a number of software related guidance documents, covering topics such as off-the-shelf software, cybersecurity, closed-loop-control, and predetermined change control...
Clinical Research Solutions
Challenges in Oncology Trials: How to Navigate the Evolving Regulatory Landscape
Setting the Scene: What Makes Oncology Clinical Trials Different? Ever increasing knowledge of the molecular basis of malignant disease has stimulated development of targeted agents. This often leads...
Clinical Research Solutions
Navigating FDA User Fee Updates for Fiscal Year 2023
As the U.S. Government begins its fiscal year on October 1, it signifies the annual revisions in FDA User Fees, which have an impact on applications and facilities associated with Prescription Drugs...
Clinical Research Solutions
Clinical Pharmacology Considerations for Peptide Drug Products, September 2023
The FDA has recently issued this draft guidance to address clinical pharmacology considerations for peptide drug products. A peptide is any polymer with 40 or fewer amino acids. These products fall...