Pink Sheet is part of Pharma Intelligence UK Limited

This site is operated by Pharma Intelligence UK Limited, a company registered in England and Wales with company number 13787459 whose registered office is 5 Howick Place, London SW1P 1WG. The Pharma Intelligence group is owned by Caerus Topco S.à r.l. and all copyright resides with the group.

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

BLAs Will Be Required To Use Structured Product Labeling Within Year

Executive Summary

FDA plans to extend structured product labeling (SPL) requirements to all biologics submissions in roughly one year, CDER Office of Business Project Support Program Manager Lisa Stockbridge said

You may also be interested in...



Structured Product Labeling guide

The Structured Product Labeling Implementation Guide for FDA Content of Labeling Submissions Version 2a/Revision 1 has been released by the agency. The document is an interim implementation guide for the "SPL Release 2a" schema used by FDA for validating SPL submissions. The agency's "DailyMed" electronic labeling system will be implemented in November using the machine-readable structured product labeling format (1"The Pink Sheet" Oct. 3, 2005, p. 12)...

DailyMed E-Labeling System Completion Awaits Physician Label Final Rule

The "DailyMed" electronic labeling system will be implemented in November; however, up-to-date information will not be fully available for roughly one year, FDA Deputy Commissioner for Medical & Scientific Affairs Scott Gottlieb said Sept. 28

Part D Discount Liability Coming Into Focus: CMS Releases Drug Cost Data

Newly released Medicare Part D data sheds light on the sales hit that branded pharmaceutical manufacturers will face when the coverage gap discount program gets under way in 2011

Topics

Latest Headlines
See All
UsernamePublicRestriction

Register

PS046458

Ask The Analyst

Ask the Analyst is free for subscribers.  Submit your question and one of our analysts will be in touch.

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