How to Comply with cGMPs by Cathy Burgess; Appendix by Neil Di Spirito
Effective Review and Approval of Digital Promotional Tactics by Dale Cooke
The Drug/Biologics Approval Process: An FDLI Primer by Brian Malkin and Scot Pittman
Bringing Your Medical Device to Market, 3rd Edition by John B. Reiss, Editor
Top 20 Food and Drug Cases, 2012 & Cases to Watch 2013 by John B. Reiss and Gregory J. Wartman, Editors
Brazilian Drug and Medical Device Regulation: A Practical Guide by Edited by: Carlos T. Angulo and Areta L. Kupchyk
Advertising and Promotion for the Pharmaceutical, Medical Device, Biological, and Veterinary Medicine Industries by
FDLI International Conference: China-US Updates in Food and Drug Law by
2013 FDLI Annual Conference by
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
2012 Annual Conference: Working in the Food and Drug Law Space: Challenges and Opportunities Audio by
In the last few years, the U.S. Food and Drug Administration (FDA) has become much more inspection-oriented and enforcement-minded. ...
To date, the regulatory environment for gluten-free labeling on food and alcohol products has been nebulous to say the least...
It has been estimated that over seventy per cent of food products sold in Canada are imported from other countries and that most domestic...
This issue of our Policy Forum (Volume 3, Number 8, April 24, 2013) — In the Aftermath of Parens Patriae: Can Privat...
(A Response to Mark E. Greenwold’s ‘What Standards Should FDA Apply in Ruling on Applications for Substantial Equivalence for...
This issue of Policy Forum (Volume 3, Number 6, March 27, 2013) – Biosimilar Naming: How Do Adverse Event Reporting Data Suppo...
This article explores whether private regulation of food safety may fill in the gaps of statutory food reforms such as the Food Moderniza...
FDA transparency effort continued, including the Secretary’s adopting eight measures to improve access to Agency information and ac...
Most international health-related standards are voluntary per se. However, the incorporation of international standard-making into WTO ag...
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 ...