Abbreviated New Drug Application process
E642120
The Abbreviated New Drug Application process is the U.S. regulatory pathway that allows generic drug manufacturers to gain FDA approval by demonstrating bioequivalence to an already approved brand-name drug without repeating full clinical trials.
Statements (49)
| Predicate | Object |
|---|---|
| instanceOf |
drug approval process
ⓘ
regulatory approval pathway ⓘ |
| administeredBy | FDA Center for Drug Evaluation and Research NERFINISHED ⓘ |
| applicableTo | small-molecule drug products ⓘ |
| appliesTo | generic drugs ⓘ |
| associatedWith | Orange Book listings NERFINISHED ⓘ |
| basedOn | Abbreviated New Drug Application NERFINISHED ⓘ |
| country |
United States of America
ⓘ
surface form:
United States
|
| difference |
does not require independent demonstration of clinical efficacy
ⓘ
relies on prior findings of safety and effectiveness for reference listed drug ⓘ |
| differsFrom | New Drug Application process ⓘ |
| documentationForm | electronic common technical document ⓘ |
| doesNotRequire |
full clinical efficacy trials
ⓘ
independent safety trials equivalent to new drug applications ⓘ |
| goal |
to avoid unnecessary duplication of clinical trials
ⓘ
to increase availability of lower-cost generic medicines ⓘ |
| impact | reduces drug costs for patients and payers ⓘ |
| includesStep |
FDA filing review
ⓘ
bioequivalence assessment ⓘ facility inspection ⓘ final approval or tentative approval decision ⓘ labeling review ⓘ submission of ANDA to FDA ⓘ substantive scientific review ⓘ |
| involves | patent and exclusivity considerations ⓘ |
| jurisdiction | Center for Drug Evaluation and Research NERFINISHED ⓘ |
| keyRequirement | demonstration of bioequivalence to a reference listed drug ⓘ |
| mayResultIn |
approval
ⓘ
complete response letter ⓘ tentative approval ⓘ |
| notTypicallyUsedFor | biologic products ⓘ |
| purpose | to provide a pathway for approval of generic versions of previously approved drugs ⓘ |
| referenceProduct | reference listed drug ⓘ |
| referenceProductType | previously approved brand-name drug ⓘ |
| regulatoryAgency |
FDA
NERFINISHED
ⓘ
U.S. Food and Drug Administration NERFINISHED ⓘ |
| regulatoryBasis | Federal Food, Drug, and Cosmetic Act NERFINISHED ⓘ |
| regulatorySection | Section 505(j) of the Federal Food, Drug, and Cosmetic Act ⓘ |
| relatedTo | New Drug Application process ⓘ |
| requires |
bioequivalence studies
ⓘ
chemistry, manufacturing, and controls information ⓘ drug product quality data ⓘ good manufacturing practice compliance ⓘ in vitro dissolution data where applicable ⓘ labeling information ⓘ patent certification ⓘ stability data for the drug product ⓘ |
| shortName | ANDA process ⓘ |
| supports | generic drug competition ⓘ |
Referenced by (1)
Full triples — surface form annotated when it differs from this entity's canonical label.
Drug Price Competition and Patent Term Restoration Act of 1984
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establishes
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Abbreviated New Drug Application process
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