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

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

UsernamePublicRestriction

Register

PS046458

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