Drug Evolution Process of IND, NDA & ANDA

Drug development is divided into types. The first type is Pre-clinical phase, usually takes 3 to 4 years to complete. If fruitful, this phase is followed by an appeal to the FDA as an Investigational New Drug (IND). After the approval by IND, the next stages are of clinical phases 1, 2, & 3, which require approximately 1-3 years for completion. Importantly, throughout the process of FDA, an investigator leading the clinical trials to communicate with each other so that safety is monitored. The manufacturer then files a New Drug Application (NDA) with the FDA for approval. This appeal can either be approved/ rejected; otherwise the FDA might request further study before making a quick decision. Following the acceptance, the FDA can also request the manufacturer to conduct additional post-marketing studies.  On average the entire process takes between 8 to 12 years.

Drug development is divided into types. The first type is Pre-clinical phase, usually takes 3 to 4 years to complete. If fruitful, this phase is followed by an appeal to the FDA as an Investigational New Drug (IND). After the approval by IND, the next stages are of clinical phases 1, 2, & 3, which require approximately 1-3 years for completion. Importantly, throughout the process of FDA, an investigator leading the clinical trials to communicate with each other so that safety is monitored. The manufacturer then files a New Drug Application (NDA) with the FDA for approval. This appeal can either be approved/ rejected; otherwise the FDA might request further study before making a quick decision. Following the acceptance, the FDA can also request the manufacturer to conduct additional post-marketing studies.  On average the entire process takes between 8 to 12 years.

  • IND China, Asia Pacific, USA, Globally
  • NDA China, Asia Pacific, USA, Globally
  • ANDA China, Asia Pacific, USA, Globally
  • Biologic License Application (BLA)
  • Current Status and Trends of IND/NDA Practices in China

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Drug Evolution Process of IND, NDA & ANDA Conference Speakers