---
title: Insights | Nicole Gallo
description: News & Updates from Halloran Consulting Group
---

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# Nicole Gallo

## Blog Post by Nicole Gallo

[

Nicole GalloJan 8, 2026 1:15:01 PM4 min read

## 2026 Regulatory Momentum at the U.S. FDA

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](https://hallorancg.com/insights/2026-regulatory-momentum-at-the-u.s.-fda)[

Nicole GalloOct 14, 2025 3:13:56 PM2 min read

## Cell and Gene Therapy International Conference Reflections

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](https://hallorancg.com/insights/cell-and-gene-therapy-international-conference-reflections)[

Nicole GalloJan 13, 2025 11:19:45 AM4 min read

## Early FDA Engagement is Essential

Navigating the FDA review process for investigational new drugs (INDs) is the critical ...

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](https://hallorancg.com/insights/early-fda-engagement-is-essential)[

Nicole GalloApr 8, 2024 12:15:00 PM1 min read

## Successful Planning for an Original NDA / BLA Submission

This comprehensive webinar offers an insightful exploration into the intricate landscape ...

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](https://hallorancg.com/insights/2024/04/08/successful-planning-for-an-original-nda-bla-submission)[

Nicole GalloJun 13, 2023 9:08:00 PM17 min read

## Advanced Therapy Medicinal Products: Recent US Approvals, Upcoming Guidance

This article was originally published in Regulatory Focus by RAPS

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](https://hallorancg.com/insights/2023/06/13/advanced-therapy-medicinal-products-recent-us-approvals-upcoming-guidance)[

Nicole GalloMar 14, 2023 5:24:00 PM4 min read

## FDA Issues Final Guidance About Multiple Endpoints in Clinical Trials

On October 21, 2022, the U.S. Food and Drug Administration (FDA) issued the “Multiple ...

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](https://hallorancg.com/insights/2023/03/14/fda-issues-final-guidance-about-multiple-endpoints-in-clinical-trials)[

Nicole GalloFeb 14, 2023 3:21:00 PM5 min read

## Critical Considerations to Advance Gene Therapy Products for Rare Diseases

The U.S. Food and Drug Administration (FDA) Center for Biologics Evaluation and Research ...

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](https://hallorancg.com/insights/2023/02/14/critical-considerations-to-advance-gene-therapy-products-for-rare-diseases)[

Nicole GalloMay 9, 2022 11:21:00 AM6 min read

## FDA Requires Randomized Data to Support PI3K Inhibitor Approvals

The Oncologic Drugs Advisory Committee (ODAC) convened a meeting on April 21, 2022, to ...

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](https://hallorancg.com/insights/2022/05/09/fda-requires-randomized-data-to-support-pi3k-inhibitor-approvals)[

Nicole GalloNov 1, 2021 11:46:00 AM1 min read

## The Launch of Bespoke Gene Therapy Consortium (BGTC)

On Wednesday, October 27, 2021, the NIH announced that they will be partnering with the ...

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](https://hallorancg.com/insights/2021/11/01/the-launch-of-the-bespoke-gene-therapy-consortium)[

Nicole GalloApr 13, 2021 1:54:00 PM5 min read

## Cell and Gene Therapy Initial IND Submission Considerations

You’re at a small, emerging biotech and you’ve got a unique cell and gene therapy in ...

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](https://hallorancg.com/insights/2021/04/13/cell-and-gene-therapy-initial-ind-submission-considerations)

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