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Successful NDA submissions require a foundational regulatory and clinical strategy that can adapt to the challenges and competing priorities of the drug development process and ultimately drive the program forward. Read our case study to learn more about the approaches and activities we implemented to meet timeline goals
A very common yet very critical question for a 505(b)(2) development program is “What clinical studies are needed to support the marketing application?” The clinical program required is very dependent upon the specifics of the new drug product and indication, and the studies necessary to gain approval can range from a single bioequivalence study to a more comprehensive Phase 2 and Phase 3 clinical program.
UNITY Biotechnology partnered with Rho to execute a complex and fast-moving Osteoarthritis program with three concurrent clinical trials and database locks scheduled during the height of the COVID-19 pandemic. In this webinar, hear from both the Sponsor and CRO about the creative solutions they implemented and how they worked together to pivot quickly and meet critical study timelines in the midst of the pandemic.
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.