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Navigating FDA Pre-Submission Meetings

This NCI SBIR PLAN Webinar Series focuses on: Navigating FDA Pre-Submission Meetings: INTERACT, Pre-IND, and Q-Sub Explained

Speakers from NCI SBIR-funded startups and NIH SEED Entrepreneurs in Residence will shared advice on determining the right timing for FDA engagement, preparing effective briefing materials, and using FDA feedback to shape development strategy, reduce risk, and support fundraising and commercialization.

Additional topics covered include:
•    Differences across drug, biologic, and device regulatory pathways
•    When to engage FDA across INTERACT, Pre-IND, and Q-Sub pathways
•    Preparing effective briefing packages and questions
•    Using FDA feedback to de-risk development and inform strategy
•    Leveraging FDA engagement to support fundraising and SBIR applications

Watch the recording here.

Please find advice videos from each panelist below.

 

Cordance Medical

Slide with PLAN webinar title and Cordance Medical.

Watch this video to learn about:

  • Navigating device regulatory pathways
  • Sequencing Q-Subs for maximum impact
  • Using Q-Subs to shape IDE and clinical strategy
  • Breakthrough Device Designation strategy
  • Leveraging the TAP program

Myosin Therapeutics

Slide with PLAN webinar title and Myosin Therapeutics.

Watch this video to learn about:

  • Timing your Pre-IND meeting
  • Building an effective Pre-IND briefing book
  • Key questions to ask at Pre-IND
  • Using regulatory consultants effectively
  • Orphan Drug and Fast Track designation strategy

Vaxiion Therapeutics, Inc.

Watch this video to learn about:

  • Novel CBER-regulated modalities
  • How INTERACT meetings can de-risk development
  • The right stage for engaging in Pre-IND meetings
  • Leveraging FDA engagement to support fundraising
  • Building regulatory strategy as a lean startup

 

NIH SEED EIRs

For Drugs and Biologics

Watch this video to learn about:

  • FDA Guidance Early in Therapeutic Development
  • Overview of INTERACT and pre-IND meetings at the Center for Biologics Evaluation and Research (CBER) and the Center for Drug Evaluation and Research (CDER)
  • Preparation Tips for INTERACT and Pre-IND Briefing Packages
  • Resources at CBER and CDER

For Devices/Diagnostics

Watch this video to learn about:

  • Key interaction pathways for medical devices at the FDA
  • Overview of the Q-Submission (Q-Sub) program and Pre-Sub meetings at the Center for Devices and Radiological Health (CDRH)
  • Preparation Tips for Pre-Submission Meeting
  • Resources at CDRH
  • Posted:

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