Navigating FDA Layoffs: How Policy Layoffs May Impact Generic Drug Development
Layoffs at the Office of Generic Drug Policy Could Slow Development—but Strategic Guidance Can Help Sponsors Stay on Track
Clinical Research Solutions
Did you know that 1 in 44 American children is autistic, and approximately 5.4 million adults in the U.S. are autistic as well? It's an extraordinarily diverse group too, as autism spectrum disorder...
Clinical Research Solutions
It’s finally here, a guidance on how to handle medicinal products imported from outside EU/EEA. If you’ve ever wondered what the expectations are on these imported medicinal products, you’re in for a...
Clinical Research Solutions
When considering a decentralized approach to your clinical trial, it can be confusing or overwhelming to identify a provider that will truly understand and support specific study needs. ProPharma...
Clinical Research Solutions
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...
Clinical Research Solutions
Decentralized Clinical Trials (DCTs) is a buzzword in the clinical research space that has been gaining notoriety because of the COVID-19 pandemic. It’s a concept that revolves around bringing...
Clinical Research Solutions
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...
Clinical Research Solutions
In order to incentivize the development of therapies (drugs biologics) to fill unmet medical needs for treatment of serious conditions, the FDA has developed various programs to expedite drug...