The submission of New Drug Applications (NDA) and Abbreviated New Drug Applications (ANDA) is a critical step in the drug development process. These applications are often met with rejections in the form of Refuse to Receive (RTR) and Refuse to File (RTF) letters, leading to significant delays in drug approval, financial losses, reputational damage, and delayed patient access to critical treatments.
This webinar focuses on addressing the challenges and strategies related to early rejections in product registration applications, particularly in the context of regulatory submissions to the USFDA.
What You Will Learn:
Impact of early rejections on applicants
Early rejections can have significant consequences, including delayed approval timelines, increased costs and resource utilization, negative impact on market share and revenue, and damage to reputation and credibility.
USFDA’s criteria for rejecting product registration applications
RTR and RTF rejections are triggered by various factors, like incomplete or inaccurate submissions, insufficient data or inadequate study results, and gaps in the manufacturing process and controls, to name a few.
Means of proactive identification of gaps and strategies for prevention, as well as query handling in case of rejections
How to Identify potential gaps in the application before submission, reviewing and addressing common deficiencies through quality checks and early engagement of regulatory experts, while ensuring compliance with regulatory guidelines and standards.
About the Speaker
Mona Sharma holds a master’s degree in Pharmaceutics (Formulation Development) and has around 22 years of experience in Regulatory Affairs (US, Canada, EU, UK, Russia, and CIS countries) and regulatory compliance across drug products (solid orals and sterile) and medical devices. Mona is a strong advocate for integrating technology with the art of regulatory writing and has led cross-functional initiatives championing greater efficiency in quality-medical writing and regulatory submissions.
Mona has contributed to formulating regulatory strategies, technical reviews, and guidance during the development & scale up stages, regulatory intelligence support, due diligence reviews, facility compliance GMP audits, and has expertise in the compilation of regulatory documents and dossiers. She brings in a lot of expertise and regulatory knowledge from her previous organizations, such as Sentiss Pharma Pvt Ltd, Ranbaxy Laboratories Limited, Wyeth Pharmaceuticals (USA), Merck (USA), Accumed (USA), and Dr Reddy’s Laboratories.