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...
by Heather Gillman | Jun 2, 2022 | Regulatory Resources
Our faculty can provide a complimentary webinar on regulatory strategies for medical devices and therapeutics. Contact us here to request a...
by Heather Gillman | Jun 2, 2022 | Regulatory Resources
The US healthcare market is a complex, fragmented space. Our guide and checklist will facilitate a soft-landing to help grow you business the right way in the United States. Meeting the unmet need: The key to success in US market entry is picking the right commercial...
by Heather Gillman | Jun 2, 2022 | Regulatory Resources
FDA Encourages EUAs to Pursue Premarket Submissions - January 31st, 2023 The White House’s recent announcement that the Biden Administration plans to end the public health emergency on May 11th, 2023. In a statement released on January 31st, 2023, the FDA...
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