This title slide highlights "Three Critical Early-Stage FDA Mistakes First-Time Medical Product Founders Must Avoid." Its subtitle emphasizes "Regulatory Lessons for Medical Innovators."

Three Critical Early-Stage FDA Mistakes

First-Time Medical Product Founders Must Avoid

Regulatory Lessons for Medical Innovators

Source: Regulatory Lessons for Medical Innovators | Author: [Your Name] | Date: [Today]

The slide emphasizes the importance of early regulatory planning in medical product development to avoid costly delays, rejections, and safety risks. It presents a thesis on three critical mistakes to sidestep for achieving FDA success.

Introduction

• Importance of early regulatory planning in med product dev
• Avoid costly delays, rejections, safety risks
• Thesis: 3 critical mistakes to sidestep for FDA success

Source: Three Critical Early-Stage FDA Mistakes First-Time Medical Product Founders Must Avoid

Mistake #1: Skipping Early FDA Engagement warns that avoiding early interactions with the FDA leads to delays, major pivots, and even company collapses like Theranos. It recommends engaging early through Q-Sub and Pre-IND meetings to mitigate these risks.

Mistake #1: Skipping Early FDA Engagement

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Mistake #1: Skipping Early FDA Engagement

Delays, Pivots, and Theranos Collapse – Engage Early with Q-Sub & Pre-IND Meetings

Source: Three Critical Early-Stage FDA Mistakes First-Time Medical Product Founders Must Avoid

Mistake #2 highlights the risks of inadequate preclinical safety planning, such as toxicity oversights that led to disasters like the TGN1412 trials hospitalizing 6 volunteers and fialuridine causing 5 deaths from overlooked liver toxicity. Recommendations include conducting robust toxicology studies across species, using relevant animal models that mimic human physiology, and ensuring comprehensive safety pharmacology before IND submission.

Mistake #2: Inadequate Preclinical Safety Planning

Source: 'Three Critical Early-Stage FDA Mistakes First-Time Medical Product Founders Must Avoid'

Mistake #3 in IND submissions involves poor documentation quality, with rejections often due to unclear CMC sections and disorganized data, plus FDA citing formatting issues in 30% of cases. To fix this, use the standardized CTD format, incorporate clear visuals for better comprehension, and add executive summaries for quick reviewer insights.

Mistake #3: Poor Quality in Documentation (CMC & Data Presentation)

• IND rejections stem from unclear CMC and disorganized data
• FDA cites formatting issues in 30% of IND submissions
• Use CTD format for standardized, compliant structure
• Incorporate clear visuals to enhance data comprehension
• Add executive summaries for quick reviewer insights

Source: Three Critical Early-Stage FDA Mistakes First-Time Medical Product Founders Must Avoid

The slide titled "Global Relevance" highlights how the FDA CTD format harmonizes global regulatory dossiers. It enables approvals from EMA and WHO, while supporting harmonization efforts by African regulatory authorities.

Global Relevance

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• FDA CTD harmonizes global dossiers
• Enables EMA, WHO approvals
• Supports African AMA harmonization

Source: Three Critical Early-Stage FDA Mistakes

The slide's key lessons emphasize engaging the FDA early, prioritizing safety planning, and excelling in documentation to achieve faster global market access. It closes with a call to avoid mistakes, succeed globally, and start regulatory planning today.

Conclusion

**Key Lessons

1. Engage FDA early
2. Prioritize safety planning
3. Excel in documentation

Early action = faster global market access.

Closing: Avoid mistakes, succeed globally.

Call-to-Action: Start regulatory planning today.**

Source: Three Critical Early-Stage FDA Mistakes

This title slide invites questions and reflections on regulatory strategies for medical product journeys. It concludes with a thank you message to encourage discussion.

Questions?

Reflections? Let's discuss regulatory strategies for your med product journey. Thank you!

Source: Closing slide for regulatory strategies presentation