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Feb 3, 1997 ... Pay/MCG. SEP 30. Submitter. Ash Medical Co, Ltd. The Imperial Tower. 1- l, Uchisaiwaicho come. Chiyoda-ku, Tokyo 100, Japan.
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What is the PI patient information?
What is the Prescribing Information? FDA-approved Prescribing Information (PI), also known as United States Prescribing Information (USPI), reflects FDA's finding regarding the safety and effectiveness of the human prescription drug under the labeled conditions of use.
How do you write prescribing information?
Highlights of Prescribing Information. Section 1: Indications and Usage. Section 2: Dosage and Administration. Section 3: Dosage Forms and Strengths. Section 4: Contraindications. Section 5: Warnings and Precautions. Section 6: Adverse Reactions. Section 7: Drug Interactions.
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The following heading must appear at the beginning of the TOC: “FULL PRESCRIBING INFORMATION: CONTENTS.” This heading should be in all UPPER CASE letters and bolded.
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What Are the Formats for the Prescribing Information? The Prescribing Information (PI) has two formats: “Physician Labeling Rule” (PLR) format and “old” (non-PLR) format.
What is the prescribing information package insert?
A package insert is a document included in the package of a medication that provides information about that drug and its use. For prescription medications, the insert is technical, providing information for medical professionals about how to prescribe the drug.
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