Acronyms & Definitions

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  • Protects, under certain circumstances, the first ANDA applicant to challenge a patent for the reference listed drug (RLD) listed in the Orange Book, from competition from subsequent generic versions of the same drug product for 180 days.

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  • 505(b)(2)

    NDA for a drug product for which one or more of the investigations relied upon by the applicant were not conducted by or for the application, and for which the applicant does not have the right of reference or use from the person conducting the investigation.

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  • 510(k)

    Premarket notification submission based on medical device being substantially equivalent to a product already lawfully on the market.

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    Shortened version of New Animal Drug Application (NADA) that may be submitted for approval of a new formulation of an existing animal drug that is similar to an already approved drug (used for generic animal drug products).

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  • ANDA

    Shortened version of New Drug Application (NDA) that may be submitted for approval of a new formulation of an existing drug or investigational drugs that are similar to already approved drugs (used for generic drug products). Also called 505(j) pathway.

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  • ANDS

    A submission for a new drug where, in comparison with a Canadian Reference Product (CRP), the new drug is the pharmaceutical equivalent; is bioequivalent based on the pharmaceutical and, where the minister considers it necessary, bioavailability characteristics; has the same route of administration; and has conditions of use that fall within the CRP�s conditions of use.

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  • An application for marketing authorisation that, based upon demonstrating essential similarity, does not contain the results of pharmacological and toxicological tests of the results of clinical trials.

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  • Regulatory Writing is an invaluable resource for any professional engaged in designing, composing, compiling, or commenting on regulatory documentation.

  • This compilation includes the individual medical device subsets from all four Fundamentals of Regulatory Affairs books: US, EU, Canada and International. The subsets cover the entire medical device lifecycle, from product development through postmarketing for all these regions.

  • The second edition of Global Medical Device Regulatory Strategy includes timely updates on all chapters, current information on cybersecurity and software, new international regulations and a new chapter on driving successful commercial product launches.

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