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S/ StructuredProductLabeling/default.htm FDA estimates the burden of this collection of information as follows: TABLE 1 ESTIMATED ANNUAL REPORTING BURDEN 1 Number of respondents Activity Number of responses per respondent Total annual responses Average burden per response Total hours New registrations, including new labeler codes requests ... Annual updates of registration information .......................... New drug listings .
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Yvette FAQ
Indexing Structured Product Labeling June 2008 Indexing refers to the insertion of machine-readable tags, which do not appear in actual printed labeling, that enable users with clinical decision support tools and electronic prescribing systems to rapidly search and sort product information.
The Structured Product Labeling (SPL) is a document markup standard approved by Health Level Seven (HL7) and adopted by FDA as a mechanism for exchanging product and facility information.
To get SPL and ShPP you or your partner has to: take less than the 52 weeks of maternity or adoption leave and use the rest as SPL. take less than the 39 weeks of maternity or adoption pay (or Maternity Allowance) and use the rest as ShPP.
SPL ensures control over critical product information that has led to a standard for product labeling. It is adopted by the Food and Drug Administration (FDA) to ensure patient safety and increase product usability among its consumer base.
SPL is an XML file that includes the information with which the user worked with STARS: start/end date and time, the name of downloaded data file, and plot information.
To get SPL and ShPP you or your partner has to: take less than the 52 weeks of maternity or adoption leave and use the rest as SPL. take less than the 39 weeks of maternity or adoption pay (or Maternity Allowance) and use the rest as ShPP.
Structured Product Labeling (SPL) is a Health Level Seven International (HL7) standard which defines the content of human prescription drug labeling in an XML format.
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