Understanding New Drug Application (NDA) Classification Codes is crucial for setting clear regulatory and development timelines. These codes help the FDA categorize new drugs based on their relationship to previously approved therapies.
The numerous acronyms used by the FDA, along with their distinct meanings, can be quite confusing. Beyond its own name, the FDA is filled with abbreviations that might seem like an alphabet soup of terms.
While these terms may appear overwhelming at first, they play a critical role in managing timelines, budgeting, and keeping stakeholders informed.
Knowing how the FDA will classify a new treatment is key to navigating the regulatory process. By comparing a drug to previously approved products within the same classification, developers can better chart the course for submitting a New Drug Application (NDA).
When the FDA receives an NDA, it assigns a preliminary classification code. This is revisited at the time of approval and is based on how the new drug compares to previously approved therapies.
Below table helps summarize the categories used by the FDA to classify New Drug Applications (NDAs) and streamline the review process.
With regulatory timelines affecting budgeting and strategy, knowing how your product fits into these categories can make a big difference.
NME status can be valuable for drug developers aiming to secure an expedited program designation for treatments targeting serious or life-threatening conditions. In 2023, 65% of the 55 novel drugs approved by CDER utilized one or more expedited programs, such as Fast Track or Priority Review.
Take Eli Lilly’s lymphoma treatment, Jaypirca, for instance. It was classified as an NME and granted Priority Review, shortening the PDUFA goal date to within six months. Additionally, Jaypirca received Orphan Drug status, which, while not speeding up approval, grants the company seven years of market exclusivity upon approval.
Read also:
- Whether to Submit an ANDA or 505(b)(2) Application
- Estimated Time Frames for Obtaining FDA Authorization
Resource Person: Bhupesh Pratap