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.
- 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
Recommended Sessions
- Advances In Bioavailability
- Analytical Method Development and Validation
- Bioavailability And Bioequivalence Studies
- Biopharmaceutics Classification System
- Clinical Studies
- Contract Research Organizations
- Drug Evolution Process of IND, NDA & ANDA
- Drug Formulation Procedures
- Drug Product Manufacturing
- Entrepreneur Investment
- Factors Affecting Bioavailability
- Formulation
- Medicinal Chemistry
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- Nutrient Bioavailability
- Preformulation Studies
- Regulatory Requirements
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- Targeted Therapies in Cardiovascular Regeneration - Cardiovascular-2025 (France)
- Targeting the Renin-Angiotensin-Aldosterone System (RAAS) - Cardiovascular-2025 (France)
- Technology in Pharma Sciences - MedTech-2025 (Switzerland)
- Telemedicine - Personalizedmedicine-2025 (Switzerland)
- The Future of Pharma R&D - Future Pharma 2025 (Netherlands)
- Toxicological Impacts of Air and Water Pollution - Euro Pharmacology 2025 (France)
- Toxicology and Safety Pharmacology - Pharmacology-2025 (Spain)
- Toxicology: Mechanisms and Risk Assessment - Euro Pharmacology 2025 (France)
- Transdermal and Intradermal Delivery Systems - Drug Delivery-2025 (Netherlands)
- Translational Research - Personalizedmedicine-2025 (Switzerland)
- Trending: Digital Health and Telemedicine for Rare Care - ORPHAN DRUGS 2025 (France)
- Types of Formulations - Formulations 2025 (France)
- Vaccine Delivery Technologies - Drug Delivery-2025 (Netherlands)
- Vaccine Development Against Bacterial Pathogens - Euro Antibiotics 2025 (Netherlands)
- Vaccine Drug Delivery Systems - PHARMACEUTICA 2025 (Germany)
- Vaccines & Immunotherapy - Pharma Expo-2026 (Thailand)
- Vascular Pharmacology: Focus on Endothelial Dysfunction - Cardiovascular-2025 (France)
- Veterinary Pharmacology - Pharmacology-2025 (Spain)
- Women in Rare Disease Leadership and Science - ORPHAN DRUGS 2025 (France)