News

Catawba Research Achieves Acne First-to-File

Acne First-to-File: The team at Catawba Research has recently completed a first-to-file submission for acne clinical trial . In this study, Catawba enrolled a staggering 1125 acne vulgaris subjects in 8 weeks from 12 sites. The time line for the entire project from the delivery of investigational product at the site to submission of final clinical study report was 6 months. […]

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Won't you get hip to this kindly tip, get your kicks on Route 505(b)(2). What is that?

Route 505(b)(2) vs. 505(j) Your life is consumed by the single minded challenge of developing a generic drug product by navigating the FDA’s 505(j) regulatory pathway. Your journey has finally come to an end. The FDA has issued you an approval. Congratulations! You’ve endured this journey at a great financial risk; testing your business and […]

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Catawba Research Introduces New Series of Training Videos

The quest for consistency in subjective clinical assessments, has led to the development of a number of grading methods to achieve data reliability. Whether it is the IGA, PASI, PGA or signs and symptoms scale to assess severity, the inherent nature of the subjective assessments still plays a role in impacting good reproducible and robust […]

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An Overview of GDUFA

An Overview of GDUFA Introduction to The Office of Generic Drugs (OGD) The Office of Generic Drugs (OGD) reports directly to the Director of the Center for Drug Evaluation and Research (CDER). The OGD’s mission is to ensure safe, effective, and affordable medicines for the American public. The OGD helps ensure that human generic drug products […]

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How to Choose the Right CRO

Of all the big decisions to be made when conducting a clinical trial, perhaps the biggest of them all is selecting the right CRO for the job. With all the moving parts inherent in a trial, it is critical to find the right partner, and one that can deliver results in a timely and cost-effective […]

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