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:6/23/2016)... TORONTO , June 23, 2016 /PRNewswire/ - ... Ontario biotechnology company, Propellon ... the development and commercialization of a portfolio of ... cancers. Epigenetic targets such as WDR5 represent an ... contribute significantly in precision medicine for cancer patients. ...
(Date:6/23/2016)...  The Biodesign Challenge (BDC), a university competition that ... living systems and biotechnology, announced its winning teams at ... New York City . The teams, ... at MoMA,s Celeste Bartos Theater during the daylong summit. ... curator of architecture and design, and Suzanne Lee ...
(Date:6/23/2016)... 23, 2016 Apellis Pharmaceuticals, Inc. today ... trials of its complement C3 inhibitor, APL-2. The ... ascending dose studies designed to assess the safety, ... injection in healthy adult volunteers. Forty ... a single dose (ranging from 45 to 1,440mg) ...
(Date:6/23/2016)... Pleasant Prairie, WI (PRWEB) , ... June 23, ... ... sciences consultancy focused on quality, regulatory and technical consulting, provides a free ... webinar is presented on July 13, 2016 at 12pm CT at no charge. ...
Breaking Biology Technology:
(Date:6/2/2016)... 2, 2016   The Weather Company , an IBM ... an industry-first capability in which consumers will be able to ... ask questions via voice or text and receive relevant information ... Marketers have long sought an advertising solution that ... be personal, relevant and valuable; and can scale across millions ...
(Date:5/20/2016)... May 20, 2016  VoiceIt is excited to ... VoicePass. By working together, VoiceIt and ... VoiceIt and VoicePass take slightly different approaches to ... both security and usability. ... this new partnership. "This marketing and ...
(Date:5/3/2016)... VILNIUS, Lithuania , May 3, 2016 /PRNewswire/ ... today released the MegaMatcher Automated Biometric Identification ... deployment of large-scale multi-biometric projects. MegaMatcher ABIS can ... and accuracy using any combination of fingerprint, face ... of MegaMatcher SDK and MegaMatcher ...
Breaking Biology News(10 mins):