RegulatoryGlossary Term
A comprehensive regulatory submission to the FDA containing all the data and information gathered during drug development to support approval for commercial marketing of a new pharmaceutical product.
The New Drug Application represents the culmination of years of drug development, presenting the complete body of evidence demonstrating that a new drug is safe and effective for its proposed use. This submission marks the formal request to FDA for permission to market the drug product in the United States. The NDA consolidates all data from preclinical studies, clinical trials, manufacturing process development, and labeling into a comprehensive package that regulatory reviewers evaluate to make an approval decision.
The NDA contains multiple sections organized according to the Common Technical Document format, which has been internationally harmonized across major regulatory regions. Module 1 contains administrative information and prescribing information. Module 2 provides summaries of each technical section. Module 3 details chemistry, manufacturing, and controls. Module 4 presents nonclinical study reports. Module 5 contains clinical study reports and integrated analyses of safety and efficacy. This standardized structure facilitates global development programs and simultaneous submissions to multiple regulatory authorities.
FDA review of an NDA typically requires ten to twelve months for standard review or six months for priority review. The review process involves specialists from multiple disciplines evaluating their respective sections and participating in interdisciplinary discussions. The FDA may issue Complete Response Letters identifying deficiencies that must be addressed before approval, request additional information during review, or convene Advisory Committee meetings for expert input on complex applications. Upon approval, the FDA issues an approval letter authorizing commercial distribution under specified conditions and with approved labeling.
NDA submission
"Following successful completion of two pivotal Phase III trials demonstrating superiority over placebo, the sponsor submitted the NDA containing over 100,000 pages of clinical, nonclinical, and manufacturing data."
Approval pathway
"The NDA was granted Priority Review based on the drug potential to treat a serious condition with unmet medical need, reducing the target review time from ten months to six months."
A premarket submission to the FDA demonstrating that a medical device is substantially equivalent to a legally marketed predicate device and therefore does not require premarket approval.
An FDA pathway allowing approval of drugs for serious conditions based on a surrogate endpoint or intermediate clinical endpoint reasonably likely to predict clinical benefit, with post-marketing requirements to confirm the expected benefit.
A regulatory submission to the FDA requesting approval to market a biological product in the United States, demonstrating that the product meets standards for safety, purity, and potency.
An FDA program for drugs intended to treat serious conditions where preliminary clinical evidence indicates substantial improvement over available therapies on clinically significant endpoints.
An FDA program designed to expedite the development and review of drugs intended to treat serious conditions and fill an unmet medical need, providing increased communication with FDA and eligibility for Rolling Review.
A comprehensive regulatory submission to the FDA containing all the data and information gathered during drug development to support approval for commercial marketing of a new pharmaceutical product.
The New Drug Application represents the culmination of years of drug development, presenting the complete body of evidence demonstrating that a new drug is safe and effective for its proposed use. This submission marks the formal request to FDA for permission to market the drug product in the United States. The NDA consolidates all data from preclinical studies, clinical trials, manufacturing process development, and labeling into a comprehensive package that regulatory reviewers evaluate to make an approval decision.
The NDA contains multiple sections organized according to the Common Technical Document format, which has been internationally harmonized across major regulatory regions. Module 1 contains administrative information and prescribing information. Module 2 provides summaries of each technical section. Module 3 details chemistry, manufacturing, and controls. Module 4 presents nonclinical study reports. Module 5 contains clinical study reports and integrated analyses of safety and efficacy. This standardized structure facilitates global development programs and simultaneous submissions to multiple regulatory authorities.
FDA review of an NDA typically requires ten to twelve months for standard review or six months for priority review. The review process involves specialists from multiple disciplines evaluating their respective sections and participating in interdisciplinary discussions. The FDA may issue Complete Response Letters identifying deficiencies that must be addressed before approval, request additional information during review, or convene Advisory Committee meetings for expert input on complex applications. Upon approval, the FDA issues an approval letter authorizing commercial distribution under specified conditions and with approved labeling.
NDA submission
"Following successful completion of two pivotal Phase III trials demonstrating superiority over placebo, the sponsor submitted the NDA containing over 100,000 pages of clinical, nonclinical, and manufacturing data."
Approval pathway
"The NDA was granted Priority Review based on the drug potential to treat a serious condition with unmet medical need, reducing the target review time from ten months to six months."
A premarket submission to the FDA demonstrating that a medical device is substantially equivalent to a legally marketed predicate device and therefore does not require premarket approval.
An FDA pathway allowing approval of drugs for serious conditions based on a surrogate endpoint or intermediate clinical endpoint reasonably likely to predict clinical benefit, with post-marketing requirements to confirm the expected benefit.
A regulatory submission to the FDA requesting approval to market a biological product in the United States, demonstrating that the product meets standards for safety, purity, and potency.
An FDA program for drugs intended to treat serious conditions where preliminary clinical evidence indicates substantial improvement over available therapies on clinically significant endpoints.
An FDA program designed to expedite the development and review of drugs intended to treat serious conditions and fill an unmet medical need, providing increased communication with FDA and eligibility for Rolling Review.