Pink Sheet is part of Informa PLC

This site is operated by a business or businesses owned by Informa PLC and all copyright resides with them. Informa PLC’s registered office is 5 Howick Place, London SW1P 1WG. Registered in England and Wales. Number 8860726.

This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

Printed By

UsernamePublicRestriction
UsernamePublicRestriction

FDA E-Labeling Guidance Shifts Format From PDF To Structured Product Labeling

This article was originally published in The Pink Sheet Daily

Executive Summary

Agency will accept electronic submissions in PDF or SPL until the end of the year. The switch to SPL was precipitated by a new role for electronic prescribing from provisions in the Medicare Rx law and IoM recommendations.

You may also be interested in...



FDA E-Labeling Guidance Sets Fall Goal For "Structured Product Labeling" Implementation

The final guidance provides three resources companies can access for assistance with SPL. FDA expects label changes for approved drugs will be submitted electronically using SPL by fall; the agency has not yet established a timeframe for unapproved drug labels.

FDA E-Labeling Guidance Sets Fall Goal For "Structured Product Labeling" Implementation

The final guidance provides three resources companies can access for assistance with SPL. FDA expects label changes for approved drugs will be submitted electronically using SPL by fall; the agency has not yet established a timeframe for unapproved drug labels.

FDA Electronic "Structured Product Labeling" Deadline Pushed Back To Summer 2005

FDA had been planning to process SPL through an automated system starting in January 2005. The transition to the structured product labeling format will be neither costly nor difficult for industry, the agency says.

Related Content

Topics

UsernamePublicRestriction

Register

PS058749

Ask The Analyst

Please Note: You can also Click below Link for Ask the Analyst
Ask The Analyst

Your question has been successfully sent to the email address below and we will get back as soon as possible. my@email.address.

All fields are required.

Please make sure all fields are completed.

Please make sure you have filled out all fields

Please make sure you have filled out all fields

Please enter a valid e-mail address

Please enter a valid Phone Number

Ask your question to our analysts

Cancel