NEWS

EVENTS

PUBLICATIONS

VIDEOS

Engaging Early with EMA Scientific Advice: A Strategic Advantage for Sponsors | Cromos Pharma
Engaging Early with EMA Scientific Advice: A Strategic Advantage for Sponsors For companies planning clinical trials or pursuing marketing authorization in the European Union (EU), early engagement with the European Medicines Agency (EMA) through its Scientific Advice procedure can be a game-changing strategy. This is especially true for small to mid-sized developers and non-EU sponsors who may be less familiar with the European regulatory environment. Understanding Read more
FDA vs. EMA: Navigating Divergent Regulatory Expectations for Cell and Gene Therapies | Cromos Pharma
FDA vs. EMA: Navigating Divergent Regulatory Expectations for Cell and Gene Therapies. What Biopharma Companies Need to Know Key Takeaways for cell and gene therapies (CGTs)  Stakeholders Regulatory divergence increases complexity – US Food and Drug Administration (FDA) and the European Medicines Agency (EMA) have different trial design expectations, approval pathways, and post-market requirements, making a single regulatory approach ineffective. FDA offers faster approval but with uncertainty – Expedited pathways (RMAT, Fast Track, Read more
Clinical Research Focus 39th edition | Cromos Pharma
Clinical Research Focus. 39th Edition Gepotidacin Receives FDA Approval for UTI Treatment The FDA has approved GSK’s gepotidacin (Blujepa) for treating uncomplicated urinary tract infections (uUTIs) in females aged 12 and up. Backed by strong results from the EAGLE-2 and EAGLE-3 Phase 3 trials, this is the first new oral antibiotic for uUTIs in over two decades—a significant milestone in Read more
The European Health Data Space | Cromos Pharma
The European Health Data Space (EHDS): A Game Changer for Clinical Research and Pharma? The European Health Data Space (EHDS) is an initiative introduced by the European Commission to enhance the sharing and use of health data across the EU. It aims to facilitate primary and secondary use of electronic health data while ensuring patient rights and data privacy. Primary use (for patients and healthcare providers) focuses on improving Read more
See more

Schedule a meeting

We are excited to connect with you, understand your goals, and explore how we can support your needs.

Contact us