Navigation Links
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 complete solution that allows rapid compliance with FDA guidance without need for them to build an in-house staff. This expansion, beyond human prescription drug sponsors, reflects our commitment to provide customers more value in their regulatory efforts," said Mark Gross, DCL's President. "Customers love the ease and convenience of our SPL service, and we look forward to enhancing services and offering customers best-in-class SPL conversion efforts for these additional products."

About Data Conversion Laboratory, Inc.
Data Conversion Laboratory, Inc. is a leading provider of conversion services for mission critical applications. In health sciences DCL works with over 125 sponsors worldwide to facilitate compliance with the FDA's SPL initiative. Having completed over 2000 SPL conversions, DCL has worked with more sponsors for SPL conversions than all other vendors combined.

Media Contact:
Don Bridges, Data Conversion Laboratory, Inc.
505.275.2223, dbridges @ dclab.com

# # #

Read the full story at http://www.prweb.com/releases/2008/10/prweb1544754.htm


'/>"/>
Source: PRWeb
Copyright©2008 Vocus, Inc.
All rights reserved

Related medicine news :

1. FTC Extends Final Red Flag Compliance Deadline for Creditors
2. World Renowned Champalimaud Foundation Extends its Mission with Groundbreaking for Cutting-Edge Research Center
3. Highmark Foundation Extends Subsidy for Health eTools for Schools(R) through 2013
4. Lupin Enters into a Marketing Alliance with Forest Laboratories, Inc. for AeroChamber Plus(R) Brand in the US - Extends its Franchise with Pediatricians
5. City of Tempe, Arizona Extends Contract with U.S. Preventive Medicine for Employee Health Management Program
6. Robotic surgery extends benefits to bladder cancer patients at NewYork-Presbyterian/Weill Cornell
7. MDdatacor Extends Contract with Wellmark, Inc.
8. LSUHSC study finds high-dose HBO2 therapy extends survival window after cardiopulmonary arrest
9. Sun Pharma Extends Tender Offer for Taro
10. American Heart Association Extends Sympathy to Family of Journalist Tim Russert
11. Courage Center Extends Nomination Deadline for 2008 Phillips Awards to July 3
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:10/13/2017)... ... , ... Many families have long-term insurance that covers care for a family ... for care if the client has a cognitive impairment diagnosis. , “What this ... often waived, so the benefits from their insurance start immediately,” said Mechell Vieira, owner ...
(Date:10/13/2017)... ... ... Talented host, actor Rob Lowe, is introducing a segment ... of "Success Files," which is an award-winning educational program broadcasted on PBS Member ... with passion and integrity. , Sciatica occurs when the sciatic nerve in the ...
(Date:10/12/2017)... Francisco, CA (PRWEB) , ... October 12, 2017 ... ... Dr. Cheng, are now treating sleep apnea using cutting-edge Oventus O2Vent ... apnea, a serious sleep disorder characterized by frequent cessation in breathing. Oral appliances ...
(Date:10/12/2017)... ... October 12, 2017 , ... ... in post-acute health care, have expanded their existing home health joint venture through ... AccentCare has been operating a joint venture home health company with Asante, delivering ...
(Date:10/12/2017)... ... October 12, 2017 , ... On Saturday, October 21, the Health & Wellness ... Moonlight to raise money for the American Heart Association Heart Walk. Teams of up ... work together to keep their treadmills moving for 5 hours. Treadmills will start at ...
Breaking Medicine News(10 mins):
(Date:10/2/2017)... 2017 The Rebound mobile app is poised to ... the tide of prescription drug addiction. The app empowers users ... and stepping down their dosage in a safe, controlled manner ... 2017; the first 100,000 people to sign up will enjoy ... ...
(Date:9/27/2017)... , Sept. 27, 2017  Commended for their devotion to ... awards. Ranked as number one in the South Florida Business ... in Inc. 5000 yearly list, the national specialty pharmacy has ... Armando Bardisa will soon be honored by SFBJ as ... Set to receive his award in October, ...
(Date:9/25/2017)...  EpiVax, Inc., a leader in the fields ... announced the launch of EpiVax Oncology Inc., a ... cancer vaccines. EpiVax has provided $500,000 in seed ... technologies to the new precision immunotherapy venture. Gad ... as Chief Executive Officer. Gad brings over 25 ...
Breaking Medicine Technology: