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People also ask
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What is an abbreviated new drug application an application for?
An abbreviated new drug application (ANDA) contains data which is submitted to FDA for the review and potential approval of a generic drug product.
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Which act allowed manufacturers of generic drugs to submit an ANDA or abbreviated new drug application?
The Drug Price Competition and Patent Term Restoration Act of 1984 (also known as the Hatch-Waxman Amendments) added sections 505(b)(2) and 505(j) to the Federal Food, Drug, and Cosmetic Act (FD&C Act), establishing abbreviated routes for obtaining approval for new drug applications (NDAs) and abbreviated new drug ...
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What is the Hatch-Waxman Act and Amendment?
The "Drug Price Competition and Patent Term Restoration Act of 1984," also known as the Hatch-Waxman Amendments, established the approval pathway for generic drug products, under which applicants can submit an abbreviated new drug application (ANDA) under section 505(j) of the Federal Food, Drug, and Cosmetic Act (FD&C ...
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What is the new Drug Application Act?
The law is intended to assure consumers that foods are pure and wholesome, safe to eat, and produced under sanitary conditions; that drugs and devices are safe and effective for their intended uses; that cosmetics are safe and made from appropriate ingredients; and that all labeling and packaging is truthful, ...
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Which law allows manufacturers to submit ANDA?
The ANDA process, established by the Hatch-Waxman Act of 1984, facilitates the approval of generic drugs by amending the Federal Food, Drug, and Cosmetic Act.
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What is an abbreviated new drug application regulation?
An ANDA is a request to the U.S. Food and Drug Administration (FDA) to manufacture and market a generic drug in the United States. The ANDA does not require the applicant to conduct clinical trials. An ANDA-approved drug must be bioequivalent to the brand-name drug.
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Which law permits an abbreviated new drug application for a generic drug?
Using bioequivalence as the basis for approving generic copies of drug products was established by the Drug Price Competition and Patent Term Restoration Act of 1984, also known as the Hatch-Waxman Act.
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