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Submitting NDAs: A Key Milestone in the Drug Development Journey

Blog Submitting NDAs: A Pivotal Milestone in the Drug Development Journey Developing a new drug can be lengthy and complex, often taking 12-15 years before receiving approval in the United States. A crucial component in this journey is submitting NDAs (New Drug Applications), which is both complex and challenging. The process demands considerable investment, expertise, […]

Understanding New Drug Application (NDA) and How to Submit One

Blog A Guide to the New Drug Application Process Since 1938, every new drug of a pharmaceutical company has been the subject of an approved NDA before U.S. commercialization. However, you must be careful when making a new drug application, as it requires specific information. If this is your first time submitting an NDA, you […]