Glossary Term
New Drug Application (NDA)
Definition
A New Drug Application (NDA) is a formal proposal submitted to the U.S. Food and Drug Administration (FDA) by a pharmaceutical company to seek approval for a new drug to be marketed in the United States. The NDA includes comprehensive data about the drug’s safety, efficacy, manufacturing processes, labeling, and proposed usage. It is the critical step in the regulatory process before a drug can be sold to the public.
Relevance to the MedTech Industry
The NDA process is designed to ensure that new drugs meet the necessary standards of safety, efficacy, and quality before they are made available to patients. It serves to protect public health by reviewing clinical trial data, assessing potential risks, and determining the appropriate dosage and usage instructions for the drug.
Additional Information & Related Terms
Related Terms
Investigational New Drug (IND): A regulatory submission made to the FDA before human clinical trials can begin, outlining the drug’s preclinical data and proposed clinical testing plan.
Clinical Trial Phases (I-III): The stages of human clinical trials used to evaluate a drug's safety and efficacy before it can be submitted for NDA approval.
Post-Marketing Surveillance (Phase IV): Ongoing monitoring of a drug’s safety and efficacy after it has been approved for use.
New Chemical Entity (NCE): A drug that contains an active ingredient not previously approved by the FDA.
Biologic License Application (BLA): The FDA’s approval process for biologics, similar to an NDA but for biologic products like vaccines or monoclonal antibodies.