This Friday, Oct. 20, leaders from Catawba Research will be attending an FDA Public Workshop in Silver Spring, MD. The Topic: “Overcoming Barriers to Product Development, Regulatory Approval and Commercialization of Affordable, High Quality, Generic Topical Dermatological Drug Products” The event takes place at the FDA White Oak Campus: 10903 New Hampshire Avenue – building…
CRO launches efficiency model, focusing on dermatology, women’s health and ophthalmology Over the last three years, Catawba Research has entered the pharmaceutical space to much industry attention. The North Carolina-based, multimillion dollar company has doubled its revenue and the number of studies initiated every six months. Drawing on more than 25 years of experience in…
Site Relationships When it comes to clinical research, it goes without saying that the relationship between CRO and Sponsor is of utmost importance. Sponsors are footing the bill of the clinical trial and have specific timelines and deliverables that are imperative for success. The most fruitful CRO-Sponsor relationships are built on respect, communication, and collaboration…
Taking Corporate Responsibility to Heart at Catawba Research Over the past several years, we have witnessed our company, Catawba Research (Catawba), transform into a growing and prosperous CRO. We are very fortunate to experience such success, and as a part of our mission throughout this growth has been to establish a company culture unique to…
“What? Guerrilla style clinical research? What is that?” Running a clinical trial can feel a lot like going into battle. Planning a clinical trial is fraught with complex series of obstacles and potential pitfalls that must be expertly maneuvered to achieve victory. Along the way there are key decisions that must be made and a…
Rosacea Clinical Trial Spotlight: Catawba Research is pleased to announce another achievement for a recently completed rosacea clinical trial. In this trial, Catawba enrolled more than 1000 rosacea subjects in 22 weeks from 33 sites. The time line for the entire project including investigational product at the site to delivery of final clinical study report…
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.…
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…
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…
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 are thoroughly tested and…