FDA
Regulatory Sciences
October 20, 2023
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...
Meet the Expert
Medical Information
October 19, 2023
Meet the Expert: Savannah Kay Anzaldua
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
Oncology
October 16, 2023
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...
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Medical Information
October 12, 2023
Meet the Expert: Naila Musharraf Ali
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...
Quality & Compliance
Program & Project Management
October 10, 2023
How to Avoid Blind-Spots in Your Early-Stage Drug Development Program
Navigating the landscape of vital drug development? Discover the five crucial areas that could make or break your success. Early-stage drug development encompasses the initial phases of researching,...
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Medical Information
October 5, 2023
Meet the Expert: Pinky Sharma
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...
FDA
Regulatory Sciences
September 29, 2023
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...
Quality & Compliance
Medical Information
September 25, 2023
DSCSA Requirements and Responsibilities for Drug Manufacturers (Sponsor vs CMO)
With the final deadline for complete compliance with the FDA's Drug Supply Chain Security Act (DSCSA) looming on the horizon, where do you find your organization? Although the FDA has now issued two...
Meet the Expert
Medical Information
September 21, 2023
Meet the Expert: Kamila Rocha
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...