New Drug Application (NDA) | FDA
The following resources provide summaries on NDA content, format, and classification, plus the NDA review process:
This program is intended for a drug that treats a serious/life-threatening condition and preliminary clinical evidence indicates that it may demonstrate improvement over available therapies
The NDA Drug Approval Process Explained - LegalClarity
Dec 16, 2025 · Understand the comprehensive New Drug Application (NDA) submission requirements, the FDA's stringent review timeline, and the path to commercial drug approval.
The NDA Process: A Guide to FDA Submission & Approval - Excedr
Feb 18, 2025 · Navigate the FDA's NDA process with this step-by-step guide. Learn key submission requirements, avoid pitfalls, and secure timely approval.
New Drug Application - Wikipedia
The Food and Drug Administration 's (FDA) New Drug Application (NDA) is the vehicle in the United States through which drug sponsors formally propose that the FDA approve a new …
21 CFR 314.101 -- Filing an NDA and receiving an ANDA.
(1) Within 60 days after FDA receives an NDA, the Agency will determine whether the NDA may be filed. The filing of an NDA means that FDA has made a threshold determination that the …
Navigating the NDA Submission Process: A Comprehensive Guide …
Mar 19, 2025 · Given the complexity of the process, companies must follow the outlined steps carefully to ensure the success of their application. Before submitting an NDA, a new drug …
FDA's Drug Review Process: Continued
Submission of an NDA is the formal step asking the FDA to consider a drug for marketing approval. After an NDA is received, the FDA has 60 days to decide whether to file it so it can be...
Inside the NDA: The Roadmap to FDA Drug Approval
Mar 12, 2025 · Step 1: Investigational New Drug (IND) Application. Before a company can apply for an NDA, it must conduct clinical trials under an Investigational New Drug (IND) application. …