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Study Group: Pharmaceutical Regulation and FDA Experts: Lawyers(?)

Council Members in this Study Group: 49

This study group may include professors, attorneys, former regulatory officers, and consultants knowledgeable on topics such as law and litigation issues, lobbying, policy and government, elections, antitrust, immigration, intellectual property, and legislation, among others.

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Leading Experts in this Study Group

What is a GLG Leader?
Stephen Bent, Partner & Co-Chair, Life Sciences, Foley & Lardner LLPStephen Bent
Partner & Co-Chair, Life Sciences
Foley & Lardner LLP

Stephen A. Bent is Partner and co-leader of the Life Sciences Industry Team at Foley & Lardner in Washington, DC. He is also a member of the Biotechnology & Pharmaceutical Practice Group and the Health Care and Nanotechnology Industry Teams. Mr. Bent specializes on the legal issues associated with biotechnology...

James O'Reilly
Volunteer Professor of Law
University of Cincinnati - CC

James O'Reilly is a Volunteer Professor of Law at University of Cincinnati, where he has counseled large and small drug, biotech, device and food firms since becoming a full time professor in 1998. Prof. O’Reilly’s 31 books and 137 articles have been widely cited, and as an FDA expert over many years...

Thomas Saunders, Partner, Seyfarth Shaw LLPThomas Saunders
Partner
Seyfarth Shaw LLP

Thomas Saunders is a Partner at Seyfarth Shaw in Boston, Massachusetts, where he specializes in representing emerging medical technology, biotechnology/genetic engineering and pharmaceutical concerns, particularly as to patent prosecution, patent strategy, IP licensing matters and ANDA Paragraph IV...

Marc Scheineson, Partner & Chair, Food and Drug Practice, Alston & Bird LLPMarc Scheineson
Partner & Chair, Food and Drug Practice
Alston & Bird LLP

Marc Scheineson is a Partner with Alston & Bird where he heads the firm's Food and Drug Law Practice. He has practiced food and drug law, health care law and administrative law for over 20 years in national law firms and at the FDA. His practice focuses on determining the regulatory course of least...

GLG NewsSMAnalyses by this Study Group's Experts(?)

Opinions and analyses expressed in GLG News are solely those of the author. See the Terms of Use for details.
No Company is Bullet-Proof Against Federal Contractor Risks | 06-10-2008
Analysis of: U.S. sues Honeywell over bullet-proof vests | www.latimes.com
Author: James O'Reilly, Volunteer Professor of Law, University of Cincinnati - CC

Product liability exposure of new materials makers can be severe, especially with fatal consequences of failures Internal memos re product problems can shoot company in the foot; prudent firms have a plan for controlling open-ended speculative memos in an instant-message environment Major PR and govt....

Controversy Bred By Under-Regulation: Are Genes Too Casual? | 02-04-2008
Author: James O'Reilly, Volunteer Professor of Law, University of Cincinnati - CC

Recent reports by a federal study panel, addressed in stories in the NY Times and other sources, highlight one more gap between expectations and reality in the resource-starved federal safety net for consumers. Much less is being done to oversee Gene Test kits than consumers may expect; eventually there...

RIPENING INHIBITORS: ROSY FUTURE OR BRUISED FRUIT? | 12-21-2007
Author: Thomas Saunders, Partner, Seyfarth Shaw LLP

    Product shelf-life is a major economic concern for the agricultural industry.   The biological mechanism for regulating the ripening of fruits is mediated by ethylene.     Ethylene  management is addressed in three ways: 1) Ethylene...

Paint Industry Needs Global Lead Settlement Quickly | 05-09-2007
Analysis of: Lead paint industry on the defensive | www.lawyersweeklyusa.com
Author: James O'Reilly, Volunteer Professor of Law, University of Cincinnati - CC

"Son of Asbestos" claims may sound extreme; but the lead paint makers would be prudent to collectively negotiate and fund a 50-state settlement that follow the tobacco companies' model and avoids the bankruptcy model of the asbestos-using firms. Lead injury awareness has increased and demands for public...

Defending Knock-Offs: Head-to-head With Brand Names in Trademark, Copyright, and Internet Marketing | 03-01-2007
Author: Thomas Saunders, Partner, Seyfarth Shaw LLP

-Name Brands vs, Knock-Offs: Strategies and Counter-Strategies -Vulnerabilities of Name Brand Copyrights -Why the internet Knock-Off market will always exist

View All GLG News by members of this Study Group

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  • Pharmaceuticals Manufacturer

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