Instant Access, Purchase and Download Now by Cathy Burgess; Appendix by Neil Di Spirito All pharmaceutical and biologics stakehold...
Medical device companies face extraordinary obstacles to successfully develop and market a medical device. This practical, yet comprehens...
Published for the fourth consecutive year, the Top 20 Cases book, featuring analysis and discussion of the most important food and drug c...
Instant Access, Purchase and Download Now by Dale Cooke Food and Drug Administration enforcement action for promotional activities remai...
In the last few years, the U.S. Food and Drug Administration (FDA) has become much more inspection-oriented and enforcement-minded. ...
Introduction 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...
The current issue of Policy Forum (Volume 3, Number 9, May 22, 2013) – “The Medical Device Tax and Innovation: The Last Nail?...
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 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...
Instant Access, Purchase and Download Now by Brian Malkin and Scot Pittman This publication will explain, in practical ter...
FDA advisers support approval of Merck's insomnia drug at lower doses ...read more
J&J to seek approval of more than 10 new drugs by 2017 ...read more
More lenient off-label marketing backed by PhRMA ...read more