Cell therapies have the potential to revolutionize the biopharmaceutical world, but today’s processes, logistics, and delivery make for a challenging entry into the sector’s growth curve.
Sponsor companies and contract manufacturing organizations (CMOs) have a lot to consider to develop a clear guide for how their organizations will work together effectively. In this article, practical considerations are explored in addition to the FDA’s updated guidance.
How has the U.S. Food and Drug Administration (FDA) responded to the increasing interest in patient diversity in clinical trials?
On November 23, 2016, the Food and Drug Administration (FDA) published a revised draft guidance for Submission of Quality Metrics Data. The guidance includes significant changes to the earlier quality metrics draft guidance issued by the agency on July 28, 2015.
While a high percentage of FDA 510(k) submissions are rejected the first time (69%!), yours doesn’t have to be one of them.
An intro to the FDA’s new draft guidance for Technical Considerations for Additive Manufactured Devices.
This article will provide regulatory context, address confidentiality concerns, and walk through an application based on an actual FDA 483.