Navigation Links
RegLink News Partners with FOI Services on Off-Label Use Teleconference
Date:1/4/2013

Washington, D.C. (PRWEB) January 04, 2013

RegLink News - the global drug and device regulatory newsletter publisher - is kicking off the New Year with the addition of teleconferences to its list of services for the life sciences industry. Working in partnership with FOI Services, Inc., the company that pioneered access to FDA documents in the 70s, RegLink will focus on the key regulatory and policy developments in 2013. “We are excited to be branching out into a new mode of information dissemination,” said RegLink partner Louise Zornoza, “and working with FOI is a guarantee of smooth, top notch conferences. We’re confident that their delivery and our content are a recipe for success.”

The recent Court of Appeals decision in US v. Caronia (2nd Circuit, No. 09-5006-cr, December 3, 2012) will be the topic of the first teleconference, scheduled for January 10, and it will bring together two leading experts on off-label drug promotion and constitutionally protected free speech. RegLink board member and recognized First Amendment expert Alan Bennett and Supreme Court authority Doug Hallward-Driemeier, both partners at the prestigious law firm of Ropes and Gray, will provide an assessment of the potential impact of the court decision on the promotional practices of the pharmaceutical industry as well as FDA and Department of Justice enforcement policies. RegLink partner Ansis Helmanis will moderate the discussion.

The Caronia case involved a pharmaceutical sales representative convicted of misdemeanor conspiracy for making comments to a doctor about off-label use of the prescription narcolepsy drug Xyrem. Off-label use refers to use of a drug for therapeutic indications that have not been approved by the FDA. While it is common for doctors to prescribe medication “off-label” and to talk about off-label uses in various meetings and conferences, pharmaceutical companies and their representatives are not free to do so. Drug companies currently spend millions of dollars every year on compliance and training programs to deter and detect off-label promotion by sales representatives, and spend billions more to settle allegations of off-label promotion with the government.

About RegLink:
RegLink Associates, LLC is an online publisher of two e-weekly Global Updates that provide a round-up of the previous week’s regulatory, clinical, reimbursement, commercial and health technology assessment developments worldwide. Its Global Drugs and Biologics Update and Global Medical Device Update aggregate the “What’s New” from major markets around the world by country, region and topic with links to source documents and brief translation of title and content. RegLink offers a free 30-day trial of its Updates.

About FOI Services:
FOI Services, Inc. was founded in 1975 to facilitate the flow of information under the Freedom of Information Act (FOIA). Since its inception, FOI has specialized in Food & Drug Administration information, providing a wide range of products and services. FOI maintains a private library of over 150,000 FDA documents in all categories of products regulated by the agency, and hosts teleconferences on a wide range of topics of interest to FDA-regulated industry.

For more information or to register for the January 10 Caronia teleconference, click here or call FOI Services at 800-654-1147 (+1-301-975-9400 outside the U.S. and Canada).

Read the full story at http://www.prweb.com/releases/2013/1/prweb10290679.htm.


'/>"/>
Source: PRWeb
Copyright©2012 Vocus, Inc.
All rights reserved

Related biology technology :

1. ACORN Research, LLC Announces Partnership with AdeptBio, LLC
2. Dicom Systems and USARAD.com Announce Partnership and Introduce Beta Version of XMRI.com, New System by USARAD.com
3. Palatin Technologies to Present at Windhovers Therapeutic Area Partnerships Conference
4. Van Andel Institute Partners with UNCF to Recruit Students to Biomedical Research Careers
5. BioStorage Technologies Partners with Susan G. Komen for the Cure Tissue Bank at IU Simon Cancer Center to Raise Money and Awareness for Breast Cancer Research
6. Cowen Healthcare Royalty Partners Raises $1 Billion
7. Life Technologies Partners With DaAn Gene to Develop and Commercialize Molecular Diagnostic Assays in China
8. CoreLab Partners Opens Office in Tokyo, Japan
9. Unigene Receives 2012 Drug Delivery Partnerships Industry Achievement Award
10. JBT Corporation and Swisslog Enter Into Partnership for Automated Guided Vehicles
11. RiverVest Venture Partners Sells Four Successful Life Science Companies for More than $1 Billion
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:2/27/2017)... Switzerland , February 27, 2017 A ... has indicated that researchers using animals in their research treat them ... from 26 countries, and detailed analysis of the results indicates that ... Europe to put into practice the principles of the ... ...
(Date:2/27/2017)... PRINCETON, N.J. and HAMILTON, ... Advaxis, Inc. (NASDAQ: ADXS ) ... late-stage biopharmaceutical companies focused on developing cancer immunotherapies, ... license to develop a novel cancer immunotherapy agent ... technology with SELLAS, patented WT1 targeted heteroclitic peptide ...
(Date:2/26/2017)... ... , ... Rob Lowe is a well recognized television personality, so it seems ... issues that are important to the American public and important to society at large. ... hot topic around the world for a few years. , The climate and how ...
(Date:2/24/2017)... , ... February 24, 2017 , ... Chef Jodi Abel ... scene. Making stops in several cities, she gained a number of delicious recipes ... in Stellenbosch, a town in South Africa’s Western Cape province. It is internationally ...
Breaking Biology Technology:
(Date:2/16/2017)... 2017  Genos, a community for personal genetic ... received Laboratory Accreditation from the College of American ... laboratories that meet stringent requirements around quality, accuracy ... "Genos is committed to maintaining the ... honored to be receiving CAP accreditation," said ...
(Date:2/10/2017)... Feb 10, 2017 Research and ... "Personalized Medicine - Scientific and Commercial Aspects" to ... ... Diagnosis is integrated with therapy for selection of treatment as ... detection and prevention of disease in modern medicine. Biochip/microarray technologies ...
(Date:2/8/2017)... Feb. 7, 2017 Report Highlights ... The global synthetic-biology market ... billion by 2021, growing at a compound annual growth rate ... overview of the global markets for synthetic biology. - Analyses ... 2016, and projections of compound annual growth rates (CAGRs) through ...
Breaking Biology News(10 mins):