Pearls of Wisdom
Developing a Specialized Drug? Bigger Isn’t Always Better When Choosing a CRO
In recent years, there has been an increase in the number of new drugs and therapies developed for rare diseases or specific patient populations. The FDA’s Center for Drug Evaluation and Research approved 50 new drug therapies in 2021. Of those, 26 were considered...
Indiana Life Sciences Collaboration Conference: “Impact of the New Administration: FDA, HHS, CMS, et al.”
Pearl Pathways' own Director of RA/QA Services Becki Nowatzke was honored to serve on the planning committee for this compelling event featuring an outstanding slate of keynote speakers including Jonathan Blum (Principal Deputy Administrator & COO, U.S. Centers...
Ask the Expert: How to Survive an FDA Inspection
This is the third of our “Ask the Expert” blogs, a series featuring the wisdom and seasoned insight of Pearl Pathways Advisors and Consultant Advisors. Pearl Pathways Director of QA/RA Services, Beckinam Nowatzke, was interviewed for this piece. If you have any...
Get Up to Speed on the Unique Terms Used in Getting Medical Devices Approved for Use
In a previous post, we discussed several of the terms key to the regulatory approval process for drugs and biologics. In this post, we focus on acronyms, abbreviations, and unique terms that industry insiders use in discussions about the regulation and approval of...
Ask the Expert: The Importance of Qualifying Vendors
This is the second of our “Ask the Expert” blogs, a series featuring the wisdom and seasoned insight of Pearl Pathways Advisors and Consultant Advisors. Members of the Quality and Regulatory Affairs team at Pearl Pathways were interviewed for this post. If you have...