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CMC Activities for a 505(b)(2) Development Program

While a 505(b)(2) NDA can help a drug get to market faster, the time to complete the CMC activities cannot be overlooked, and the quality data package that is required in the marketing application must be incorporated in the overall project timeline.

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Inspection & Audit Preparation in Decentralized Trials

To ensure successful end-to-end execution of a DCT, steps to ensure audit readiness must be taken. We have outlined several areas for consideration to ensure audit readiness from start-up through submission.

Blog Post

Data Integrity Considerations in Decentralized Trials

Collected data from DCTs need to be integrated with other data captured during the course of a clinical trial, and data integrity must be ensured in the absence of source data verification. Two topics will be discussed: how to manage this integration and ensure confidence in the collected data.

Blog Post

Protocol Planning and Design for Quality Decentralized Clinical Trials

Decentralized clinical trials allow a patient-centric approach to data collection and communication compared to traditional clinical trials. While additional planning may be needed to implement a decentralized trial the most important question is the same. What is the research question?

virus cell
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FDA COVID-19 Treatment Development Update

With the recent emergency authorizations of the Pfizer-BioNTech COVID-19 vaccine by the regulatory authorities in the United Kingdom, Canada, and United States, we are on the verge of a significant breakthrough in coping with the COVID-19 global pandemic.

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Nonclinical Considerations for 505(b)(2) Development Programs

Applicants planning to submit a product for approval through the section 505(b)(2) new drug application (NDA) can benefit from a less costly development program with the potential for a faster route to market than a traditional 505(b)(1) program. Sponsors submitting a product through this pathway can generally plan for a nonclinical development program that is substantially curtailed compared to what is required for submission via the section 505(b)(1) stand-alone NDA pathway.

Heather Kopetski
Blog Post

Introduction to Decentralized Clinical Trials

Many terms are used to describe decentralized clinical trials (DCTs) such as ‘virtual’, ‘remote’, ‘site-less’, and ‘hybrid’ but what is the exact definition? The FDA recently defined DCTs as the decentralization of clinical trial operations where technology is used to communicate with study participants and collect data. We outline the different approaches to implementing DCTs.