What to know about FDA INTERACT meetings

When timed carefully, early feedback collected during an FDA INTERACT meeting can lead to tremendous time and cost savings. But what is the optimal timing for these meetings, and how should you prepare?

Our regulatory expert and former FDA regulator Steve Winitsky shares his advice on planning and preparing for an effective INTERACT meeting.

Open PDF

Return to Insights Center

Related Insights

Blog

BIOSECURE Act: Implications for US-based drug developers

Apr 10, 2024

Video

Cell & Gene Therapies: A Regulatory Update

Jul 22, 2022

Article

New FDA Guidance Addresses the Need for Data-Generation Strategies Across the Drug Development Lifecycle

May 10, 2022

Blog

Maintaining Data Integrity for Quality and Compliance – Essential Despite Pandemic Disruptions

May 16, 2022

Podcast

RBQM Podcast Series | Episode 3: Staying within the Guardrails: How to Push the Boundaries in a Highly Regulated Industry

Jun 16, 2022

Article

8 things you need to know about eCTDs in China

Jul 1, 2022

Blog

Preparing for the New Era of Hybrid Regulatory Inspections

Jul 11, 2022

Article

EU Orphan Drug Designation – overcoming regulatory challenges

Jul 20, 2022

Blog

U.S. drug price reform of 2022: What does the Inflation Reduction Act mean for drug manufacturers?

Aug 17, 2022

Article

New endpoints for early-stage cancer are gaining regulatory traction

Jan 28, 2022

Article

Q&A Project Optimus: What you need to know

Oct 11, 2022

Article

Relyvrio Approval: Lessons Learned

Oct 31, 2022