by Waylon Wright | Sep 14, 2017
A US Food and Drug Administration (FDA) official stated that two draft guidances detailing when a new 510(k) is required for changes to medical devices and their software are on schedule to be finalized ahead of the of the November 8, 2017 deadline set by the 21st...
by Waylon Wright | Sep 6, 2017
Gretchen Bowker, Co-founder and COO of Pearl Pathways, will lead a session of the Health-Related Foods Track at this year’s RAPS Convergence in National Harbor, MD. The session, titled “Functional Foods and Dietary Supplements: Manufacturing, Claims, and...
by Waylon Wright | Sep 1, 2017
The U.S. Food and Drug Administration granted regular approval to the first chimeric antigen receptor T-cell (CAR-T) immunotherapy in the United States. Dubbed a “historic action” by the agency, FDA approved tisagenlecleucel (KYMRIAH®, Novartis Pharmaceuticals Corp.)...
by Waylon Wright | Aug 30, 2017
Pearl Pathways announces a partnership with VisionTech Partners, the parent of Indiana’s most active angel investing group, to fuel Indiana’s life science startup community. The Pearl Pathways-VisionTech Partners alliance will focus on three essential goals....
by Waylon Wright | Aug 25, 2017
The U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) have signed a new confidentiality commitment. The commitment to share confidential info marks a milestone in the process to implement mutual recognition of drug manufacturing facility...