On April 29, 2024, FDA introduced a significant regulatory shift affecting the landscape of diagnostic testing: the new rule governing Laboratory-Developed Tests (LDTs). Unlike commercially available tests that are subject to premarket approval by the FDA, LDTs were...
What is REMS? A pivotal role of the FDA is to protect public health by ensuring the safety and efficacy of drug products. In this pursuit, one of the key tools used by the Agency is the Risk Evaluation and Mitigation Strategies (REMS) program, established in 2007...
Versiti, a national leader in blood health innovation, today announced the acquisition of Pearl Pathways, a recognized, trusted advisor and preferred partner for enabling innovative and expedited life science product development. Based in Indianapolis, Pearl Pathways...
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...
Robert Seevers, Senior Advisor at Pearl Pathways, will share insights during an Indiana Health Industry Forum (IHIF) webinar on Tuesday, March 16, 2021. The lunch event, "Pre-Clinical Pathways: Start Off On the Right Foot", is part of IHIF's recurring Life Sciences...
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...
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,...
Pearl Pathways announces the hiring of Emily Baumann as a Clinical Research Analyst. Emily brings over four years of experience in global clinical trial project management and medical affairs to the Pearl Pathways Clinical Services team.Emily's expertise...
Session Title: Don’t Blow Your Big Chance: How to Win with FDA and EMA RegulatorsRobert Seevers, Senior Advisor at Pearl Pathways, will speak during this session and participate in the panel discussion as an expert on the topic. Session synopsis: The...
Session Title: The Trials and Tribulations of Handling Legacy Products from a GMP and Regulatory PerspectiveJohn Lockwood, Director of RA/QA Services, will serve as the session leader and Mark Slisz, Senior Advisor, will speak as one of the subject matter...