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DCL Extends Structured Product Labeling (SPL) Services to Meet New FDA Requirements; Support Now Offered for CDER, CBER, CDRH, CVM and ONP Products
Date:10/30/2008

Data Conversion Laboratory, Inc. (DCL) (www.dclab.com), announced the availability of enhanced Structured Product Labeling (SPL) services to meet the recently announced FDA requirements for SPL submissions of CDER (Human Prescription Drugs), CBER (Biologics), CDRH (Medical Devices), CVM (Veterinary Medicine), and ONP (Over-the-Counter) products.

Philadelphia, PA, and New York, NY (PRWEB) October 30, 2008 -- Data Conversion Laboratory, Inc. (DCL) (www.dclab.com), a leader in conversion services to pharmaceutical and health care organizations, announced the availability of enhanced Structured Product Labeling (SPL) services to meet the recently announced FDA requirements for SPL submissions of CDER (Human Prescription Drugs), CBER (Biologics), CDRH (Medical Devices), CVM (Veterinary Medicine), and ONP (Over-the-Counter) products.

While SPL has been required for CDER products for three years, the FDA is expanding the requirements to include Establishment Registration and NDC Labeler Code Requests. In addition, the FDA announced the requirement of SPL submissions for other FDA divisions (Animal and Veterinary Health, Biologics, Medical Devices and Over-the-Counter).

The extended services allow DCL customers to be fully compliant with FDA guidance without the need for extensive in-house expertise.

Howard Shatz, DCL's SPL Project Manager, notes that "Besides expanding the range of products requiring SPL, the FDA has also expanded the supporting information needed for a label submission. As we have done with SPL all along, we are making it as simple as possible for sponsors to have a fully compliant submission without the hassle."

"We are focused on providing customers with a comple
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