by Heather Gillman | Jul 28, 2026 | Resources, White Paper
A 2026 QNova LifeSciences Report Written by: Jim Sergi INTRODUCTION The pathway for transitioning to a successful US FDA IND for a clinical-stage drug company is a crucial step in the development lifecycle of a product, as a favorable safety profile needs to be...
by Heather Gillman | Apr 28, 2026 | Resources, White Paper
A 2026 QNova LifeSciences Report Written by: Gerald L. Klein, Roger E. Morgan, Melissa Palmer, Jamie Lazar, Freddy Byrth, Wayne M. Dankner, Jamison Chang, John Hinkle, Jim Sergi Corresponding author: Gerald L. Klein, gklein@medsurgpi.com ABSTRACT A Data and Safety...
by Heather Gillman | Apr 10, 2026 | Resources, White Paper
A 2026 QNova LifeSciences Report Written by: Jose Madrid, MHA, MBA and Janice Cattano, RN, MSN On February 2, 2026, the US Food and Drug Administration’s (FDA) medical device Quality Management System Regulation (QMSR) went into effect, replacing the Quality...
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