SPL-PLR
The Physicians Labeling Rule (PLR) adds numerous challenges to
Structured Product Labeling (SPL) submission requirements. New content,
new structure and new Highlights information added a higher
level of complexity to the original SPL creation process.
Pharmaceutical manufacturers are required
to submit their drug product labeling information to the FDA in an
XML format known as Structured Product Labeling (SPL). The FDA announced that New Drug Applications, Biologics License
Applications and Efficacy Supplements
are required to conform to the SPL-PLR format. In addition, all NDAs,
BLAs and Efficacy Supplements must
change to the SPL-PLR format during a scheduled 7-year
implementation plan.
Reed Tech offers Highlights
Information Consulting Services to assist sponsors meet
the challenges of the new PLR guidelines and generate
new content. Reed
Tech is teamed with Quadrant
eLabeling Services LLC to provide pharmaceutical manufacturers with
integrated Structured Product Labeling – Physicians
Labeling Rule (SPL-PLR) services: conversion
services plus authoring and/or review of Highlights Text.
Contact Reed Tech for more information
Please
contact Ben McGinty for more information about our SPL-PLR services
Ben McGinty
Senior Director, Business Development
bmcginty@ReedTech.com
+1-215-441-6466
Reed Technology and Information Services
Inc.
7 Walnut Grove Drive
Horsham, PA
19044
U.S.A.
+1-215-441-6400
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