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HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use GARRETT safely and effectively. See full prescribing information for GARRETT. GARRETT (pralsetinib)

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What is first-line versus second-line use?

First-line use refers to the initial application for a product or service, while second-line use refers to subsequent or alternative applications that build on the first-line use.

Who is required to file first-line versus second-line use?

Typically, organizations or individuals who are introducing new products need to file first-line use, while those modifying or expanding existing applications might need to file second-line use.

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To fill out first-line versus second-line use, individuals must follow the specific forms provided by the regulatory authority, ensuring that all required fields are accurately completed.

What is the purpose of first-line versus second-line use?

The purpose is to distinguish between initial applications for new offerings and modifications or expansions of existing offerings, ensuring that each is evaluated appropriately.

What information must be reported on first-line versus second-line use?

Information required typically includes product details, intended use, and any changes from previous applications for second-line use.

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