New Drug Application (NDA)

Key facts

Legal basis

Section 505(b) of the Federal Food, Drug, and Cosmetic Act

Regulations

21 CFR Part 314

Reviewed by

FDA Center for Drug Evaluation and Research (CDER)

PDUFA review goals

Standard 10 months, priority 6 months (from filing date for NMEs)

Two routes

505(b)(1) stand-alone application or 505(b)(2) application

What is a New Drug Application?

An NDA is the application behind most brand-name small-molecule drugs. Before submitting one, a sponsor usually runs clinical trials under an Investigational New Drug (IND) application, then compiles the results into a package the FDA uses to decide whether the benefits of the drug outweigh its risks.

The effectiveness standard is "substantial evidence" from adequate and well-controlled investigations, plus evidence the drug is safe under its proposed labeling. The FDA also inspects manufacturing sites and negotiates the final prescribing information.

Most biologics, such as monoclonal antibodies and vaccines, are approved through a Biologics License Application (BLA) instead. Generic copies of NDA drugs use the Abbreviated New Drug Application (ANDA).

How an NDA moves through review

A typical path from submission to decision:

• Submission: clinical and nonclinical study reports, chemistry, manufacturing and controls (CMC) data, proposed labeling and patent information.
• Filing review: within 60 days the FDA decides whether the application is complete enough to review, or issues a refuse-to-file letter.
• Substantive review: medical, statistical, pharmacology and CMC reviewers assess the data, sometimes with input from an advisory committee.
• Action: the FDA issues an approval letter or a Complete Response Letter (CRL) listing deficiencies the sponsor must address.
• After approval: the NDA holder keeps patent listings current in the Orange Book, files postmarketing reports and submits supplements for label or manufacturing changes.

Why the NDA matters

The NDA number is a stable identifier for a brand product family. It links approval history in Drugs@FDA, patents and exclusivities in the Orange Book, labeling, and the National Drug Codes a labeler lists under that application.

NDA timing drives commercial planning. Analysts track submission and user fee goal dates to forecast launches, and track the patents and exclusivities attached to an NDA to estimate when generic competition can start. The FDA also classifies each NDA by chemical type, such as Type 1 for a new molecular entity, which separates true innovation from reformulations.