Clinical Research Solutions
EMA’s Regulatory Science Strategy to 2025 is on Track
Key messages from the mid-point achievements report To strengthen regulatory and scientific support for innovative medicines and diagnostics development, in March 2020 EMA published its Regulatory...
Clinical Research Solutions
How to Maximize the Value of Cell and Gene Therapy Products: 5 Tips for Success
This article has been updated since its original publication date. Product development is an extremely time consuming and challenging process for any pharmaceutical, biotechnology, or medical device,...
Clinical Research Solutions
The Future of UK Clinical Research Delivery
ProPharma applauds the myriad of recent, positive developments for clinical trials in the UK, representing the biggest overhaul in UK clinical trials in two decades. Lord O’Shaughnessy Clinical Trial...
Clinical Research Solutions
Ban on Titanium Dioxide (E171) on the EU Food Market: What Are the Consequences for Medicines?
Use of Titanium Dioxide in the EU Food Market In 2021, the European Food Safety Authority (EFSA) investigated the safety of the white coloring agent titanium dioxide (TiO2) and concluded that the...
Regulatory Sciences
FDA Accelerated Approval Pathway: A Potential Missed Opportunity for Sponsors
The accelerated approval provisions of FDASIA in section 506(c) of the FD&C Act provide that FDA may grant accelerated approval to: . . . a product for a serious or life-threatening disease or...
Clinical Research Solutions
What You Need to Know About Developing Vaccines
An unlikely beacon of hope from the otherwise disastrous Covid pandemic, may come in the form of renewed attention towards approaches to vaccine development. The Importance of Vaccines The...
Clinical Research Solutions
Prescription Drug User Fee Act (PDUFA) VII and Type D Meetings: A New Mechanism for Interacting with FDA
For those who have been awaiting Congressional reauthorization of PDUFA, the wait is over. On September 30, 2022, the President signed into law the FDA User Fee Reauthorization Act of 2022. We...
Clinical Research Solutions
What You Need to Know About CBER Pre-IND Meetings
The FDA provides several opportunities to hold meetings with Sponsors to gain clarification and agreement on the development of medicinal products. At the preliminary stages of development, one such...
Clinical Research Solutions
CAR-T Cells: Challenges, Lessons Learned, and Guidance for the Clinical Development
It comes as no surprise to any pharmaceutical or biotech company that planning the clinical development of CAR-T cells is an extremely challenging endeavor: high efficacy is expected in each targeted...
Clinical Research Solutions
How to Comply with the Nitrosamine Regulations for Your New Drug Product Marketing Applications
Introduction: Are you in the development phase for your medicinal product? Have you assessed your manufacturing processes with respect to the requirements for investigating the potential presence of...