File or Receive? Decoding FDA’s Early Rejection Language for NDA and ANDA

Unlock critical insights into FDA’s early rejection language for NDA and ANDA submissions in our latest Regulatory Affairs (RA) webinar.

Key Highlights:

• Understanding the impact of early USFDA rejections on timelines, cost, and credibility
• USFDA’s criteria behind RTR and RTF decisions
• Common submission gaps leading to early rejection
• Strategies to proactively identify and mitigate deficiencies
• Best practices for query handling and regulatory communication
• Expert guidance on strengthening NDA/ANDA submission readiness

Speaker

Mona Sharma, Vice President & Head, Regulatory Affairs and Medical Writing

Mona holds a master’s degree in Pharmaceutics (Formulation Development) and brings over 22 years of global Regulatory Affairs experience across the US, Canada, EU, UK, Russia, CIS countries, and multiple product categories. She has extensive expertise in regulatory intelligence, strategy development, GMP audits, and dossier compilation, with prior experience at top organizations including Sentiss Pharma, Ranbaxy, Wyeth, Merck (USA), Accumed (USA), and Dr. Reddy’s Laboratories.