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  1. Advancing Regulatory Science

2024 FDA Broad Agency Announcement Day Agenda

2024 FDA Broad Agency Announcement Day

November 14, 2024, 1:00 p.m. - 4:00 p.m. EST

Agenda

All times are Eastern Standard Time. Please see the event page for additional information.

Time Agenda item Presenter
1:00 p.m.

Welcome and Opening Remarks

# FDA Regulatory Science Framework and an overview of the new BAA Announcement

Ms. Shaila Shaheed, ORES

Ms. Vidya Vish, OAGS

1:10 p.m.

FY 2025 FDA Funding Priorities *

  # BsUFA III Research Priorities

  # Rare Diseases Research Priorities 

  # CDRH Highlighted Research Areas of Interest

  # Oncology Research Priorities

  # Medical Countermeasures Initiative Research Priorities

  # One Health Research Priorities

  # Women's Health Research Priorities

BAA Application Overview

  # Application Process and Requirements

  # Award Process and Requirements

Question and Answer Panel

 # Review of questions submitted via webinar Q&A pod, and in advance to FDABAA@fda.hhs.gov

 

Dr. Darlese Solorzano, CDER

Dr. Bridget Nugent, CDER

Dr. Michele Lee, CDRH

Dr. Rebekah Zinn, OCE

Dr. Robert Orr, ORES

CAPT Brianna Skinner, ORES

Dr. Joyce Obidi, OWH

 

Dr. Kinnera Chada, ORES

Mr. Ian Weiss, OAGS

 

 

Panel Members: ORES & OAGS

3:55 p.m. Adjourn and Closing Remarks
* Each presentation will be followed by a 5-minute Q&A.

Note: Recording of the full event (including closed captioning and an audio transcript, presentation slides, and responses to all questions will be posted on the event page.

Acronyms

CDER - Center for Drug Evaluation and Research

CDRH - Center for Devices and Radiological Health

OAGS - Office of Acquisitions and Grants Services

OCE - Oncology Center of Excellence 

ORES - Office of Regulatory and Emerging Science 

OWH - Office of Women’s Health

 

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