Guide to U.S. Import Requirements for Cosmetics and Other Personal Care Products - An FDLI Primer by Kathleen Cannon (Co-Editor-In Chief) and Sarah Roller (Co-Editor in Chief) Contributors: Kathleen Cannon, Grace W. Kim, Jennifer L. McDowell, Bridget M. Richardson
Food Law and Regulation, Inspection and Enforcement – an FDLI Primer by Marc C. Sanchez
The Regulation of Medical Devices in Canada by Sara Zborovski, Partner, Davis LLP Andy Radhakant, Partner, Davis LLP Andrew Lord, Associate, Davis LLP
Bringing Your Pharmaceutical Drug to Market by Ralph Hall, Matt Hill, Neil Di Spirito
Food and Drug Law and Regulation, 3rd Edition by David G. Adams, Richard M. Cooper, Martin J. Hahn & Jonathan S. Kahan, Editors
Off-Label Communications: A Guide to Sales & Marketing Compliance, 4th Edition by Edited by Mark Carlisle Levy
Introduction to Tobacco Law and Regulation (October 2015) by FDLI
FDA’s Regulation of Tobacco Products (2015) by FDLI
The Food and Drug Law Journal Symposium: Constitutional Challenges to FDA Law & Regulation by FDLI
Introduction to Food Law and Regulation : Understanding How the Government Regulates the Food Industry – PowerPoint presentation with live audio by FDLI
An Exploration of Ethical Issues Raised by Stevens, Stryker Biotech and Similar Cases Audio by
2012 Annual Conference: Address from the Office of Chief Counsel, Former FDA Chief Counsels Roundtable Audio by
Letter from the Editor
by Judy Rein................................................................................................
What’s in a Name? Quantifying the Economic Value of Label Information
by Anthony J. Anscombe.......................
Table of Contents
FDLI’s Food and Drug Policy Forum #9 (2015), “What Does the Future Hold for Patient-Focused Drug Development?&...
Food and Drug Policy Forum Volume 5, issue 8, 2015, September, 2015.
How regulatory updates allowing for more modern test methods, prag...
Food and Drug Policy Forum Volume 5, issue 7, 2015, August 19, 2015.
Peter Huber and Paul Howard of the Manhattan Institute for Poli...
Vaccines represent one of the greatest achievements of medicine, dramatically reducing the incidence of serious or life-threatening infec...
The regulation of stem cell-based therapies is challenging in many respects, given their unique safety, efficacy and quality issues. At t...
The widespread availability of drugs for personalized medicine has been an aspiration since before the human genome was sequenced. Recent...
Viewpoints on FDA: Enforcementis an invaluable resource for attorneys, manufacturers, consultants and other food and drug stakeholders, w...
A tough question - but one that FDA, pharmaceutical manufacturers, physicians, patients and the courts now are urgently trying to answer....
Second in a series of discussion on should terminally ill patients get access
to unapproved drugs?
Full Transcript from ...
GRAS, or generally recognized as safe, is an exemption that allows ingredients that are considered to be GRAS for their intended use to b...
E-cigarettes are an increasingly hot topic in the tobacco world, especially after the release of FDA’s proposed deeming regulations...
FDLI Names New President and Chief Executive Officer
Amy Comstock Rick to lead organization effective August 25th
The Food and Drug Law ...