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Press Releases
Rho to Coordinate Study Sponsored by NIAID to Assess Systemic Allergic Reactions to Pfizer and Moderna COVID-19 Vaccines
Blog Post
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.
Case Study
Successful Submission of a Complex NDA for a Breakthrough Therapy- Designated Product
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
Article
Clinical Studies Required for a 505(b)(2) Development Program
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.
Webinar
Mitigating COVID-19 Risks in a Complex Pain Program: a Sponsor and CRO Perspective
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.
