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This blog post serves as an introduction to a series of posts related to maintenance of the reliability and validity of ongoing clinical trial data during the COVID-19 pandemic. The FDA Guidance on conduct of clinical trials of medical products during the COVID-19 pandemic, released initially on March 18th and updated on March 27th (with questions and answers), provides support for industry, investigators, and Institutional Review Boards (IRBs) managing these new challenges.

Marketing application submissions, including NDAs, BLAs, and PMAs in the US, are the culmination of years of research and the final hurdle before a product makes it to market. This webinar will share tips on regulatory strategy,

This white paper examines the development and marketing application review processes for the chemistry, manufacturing, and controls (CMC) aspects of products targeting serious conditions in the context of the FDA’s […]

You may be familiar with Right-to-Try, but what does it actually mean for product sponsors? This white paper explores both Right-to-Try legislation and existing Expanded Access Programs, including: Understanding sponsor […]

Patient-centricity gets a lot of buzz, but what are the benefits of involving patients in the planning of a clinical trial?

Far too often clinical development programs fail, even when a drug or device likely had a favorable effect on disease outcome. There is considerable need for increased recognition of the […]

In this white paper, “To SPA or Not to SPA: That is the Question. Understanding Special Protocol Assessments,” David Shoemaker, SVP of Research and Development at Rho, provides strategic recommendations […]