by Waylon Wright | Jul 9, 2020
The United States Food and Drug Administration (FDA) issued a new guidance for industry related to the Coronavirus Disease 2019 (COVID-19) pandemic caused by severe acute respiratory syndrome coronavirus (SARS-CoV-2). FDA issued the guidance, titled “Development and...
by Waylon Wright | Apr 29, 2020
Robert Seevers, Senior Advisor at Pearl Pathways, will lead the RAPS Indiana Chapter webcast on Thursday, April 30.Session description: Eat your lunch and join the RAPS Indiana Chapter online for tips and tricks on how to build a positive relationship with Food and...
by Waylon Wright | Jan 16, 2020
Mark Slisz, a Senior Advisor at Pearl Pathways, will discuss why startups and independent researchers should approach the drug development process with a regulatory mindset months before their first formal interaction with FDA or other global health authorities. Mark...
by Waylon Wright | Oct 15, 2019
Pearl Pathways announces the hiring of Eric English as a Quality Assurance and Regulatory Affairs (QA/RA) Advisor. Eric brings over 18 years of experience in quality, regulatory, and auditing roles within the pharmaceutical and medical device industries, including...
by Waylon Wright | Oct 10, 2019
The U.S. Food and Drug Administration (FDA) issued a draft guidance titled “Safer Technologies Program for Medical Devices.” The guidance, released on September 18, 2019, expands upon the Safer Technologies Program which was originally described within the agency’s...