Reed Tech - Structured product label management services for the content lifecycle management of regulatory compliant spl, spl-plr and pim pharmaceutical labels.

SERVICES

- Reed Tech Services
- Reed Tech Process
- Data Capture
- Electronic Publishing
- Reedfax®

LIFE SCIENCES

- Services
- Experience
- eDRL & SPLR4
- SPL Conversion
- SPL-PLR
- Animal Health
- LabelSuite™
- LabelSentinel™ &
LabelCompare™
- PIM Services

- Contact Form
- Locations
- Directions

FEDERAL

- Small Business Policy

CAREERS

- Job Postings
- Benefits
- Directions

Home > Life Sciences Services > eDRL & SPL R4

Electronic Drug Regulation and Listing (eDRL) &
Structured Product Labeling Revision Four (SPL R4)

Are you Keeping Current with the New
Changes regarding FDAAA eDRL and SPL R4 requirements?

On July 10, 2008, the FDA announced the creation of electronic Drug Registration and Listings encompassing the following:

Discontinuation of paper submission Forms 2656, 2657, 2658

Use of SPL R4 as the electronic submission vehicle as per HL7 membership ballot passed on 5/6/08

Requirement for SPL submissions to be filed via Electronic Submission Gateway (ESG)

Initiation of the eDRL Pilot Program 7/10/08 through 5/31/09

As of 6/1/09, SPL submissions are required for Human Health, Animal Health, and Biologics and Vaccines

Affected Life Sciences Manufacturers

•	Human Health (Prescription & OTC) overseen by CDER
•	Animal Health (Prescription & OTC Drugs, OTC & VFD Feeds) overseen by CVM
•	Biologics and Vaccines overseen by CBER

FDA eDRL Roadmap


Three New SPL Implementations, Using One SPL Standard

	•	SPL-LCR NDC Labeler Code Request (Replaces Form 2656)
	•	SPL-REG Establishment Registration(Replaces Form 2656)
	•	SPL-LL Product Listing and Labeling(Replaces Forms 2657, 2658)

Reed Tech Will Help You Complywith the New FDAAA Regulations by:
	•	Providing easy-to-use data collection forms for your use or we will extract the necessary data directly from your source documents
	•	Accurately transferring Labeler, Establishment and Product information into SPL XML structure
	•	Converting SPL R3 submissions to SPL R4 submissions
	•	Establishing an Electronic Submission Gateway (ESG) for the secure transfer of submissions to the FDA
	•	Checking the presence and accuracy of data values
	•	Cross-checking SPL-LCR / SPL-REG / SPL-LL
	•	Performing in-depth validations
	•	Providing ongoing Life Cycle Management

Reed Tech has already created SPL R4 documents for the FDA eDRL Pilot Program and has received confirmation that they have passed FDA validation.

Contact Reed Tech for more information

Please contact Ben McGinty, for more information about FDAAA eDRL and SPL R4 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

Reed Technology and Information Services Inc. (Reed Tech), based in Horsham, PA, is a leader in data capture, conversion and management. Reed Tech is a member of the LexisNexis Group headquartered in New York, NY, a leading global provider of comprehensive and authoritative legal, news and business information and tailored applications. © Reed Technology and Information Services Inc. All Rights Reserved.

"Reed Tech has always been very responsive to our requests and in a most professional manner."
- Sr. Specialist, Submissions & Records Management

Member of Health Level Seven (HL7)

"HL7" and "Health Level Seven" are registered trademarks of Health Level Seven, Inc.

A member of the
LexisNexis Group