By Porter Wright on Prior to adjourning for the Memorial Say recess, the Senate, on 05/24/2012, by a vote of 96-1, passed S. 3187, the "Food and Drug Administration Safety and Innovation Act", " To amend the Federal Food, Drug, and Cosmetic Act to revise and extend the user-fee programs for prescription drugs and medical devices, to establish user-fee programs for … Continue Reading
By Porter Wright on On December 21, 2011, the International Center for Technology Assessment (ICTA), along with fellow plaintiffs Friends of the Earth (FOE), the Center for Environmental Health, Food and Water Watch, the Institute for Agriculture and Trade Policy, and the Action Group on Erosion, Technology and Concentration filed a complaint in the US District Court for the District of Norther California … Continue Reading
By Porter Wright on For decades after it was discovered, penicillin was used to combat bacteria and, eventually, almost every other disease, whether it was the appropriate treatment or not. Over time and over use of penicillin and its successor drugs, resistant strains of bacteria began to appear, to the point where, now, many strains of bacteria are almost … Continue Reading
By Porter Wright on The Food & Drug Law Institute is holding its 2nd Annual Conference on Nanotechnology Law, Regulation and Policy on February 18-19, 2009 at the L’Enfant Plaza Hotel in Washington, DC. Register here. Topics include: What progress is FDA making in implementing its Nanotechnology Task Force Report? What can FDA learn from EPA and other oversight … Continue Reading
By Porter Wright on By Laurie N. Jacques: Counterfeiting is widespread because it is lucrative and often difficult to detect. Nanowerk highlights the use of nanotechnology in the battle against counterfeit goods. Nanoencryption provides a new option for distinguishing between genuine and counterfeit goods, particularly pharmaceuticals. Drug counterfeiting is particularly problematic because it compromises patient safety in addition to … Continue Reading
By Porter Wright on Pharmos Corporation recently announced the completion of its first round of testing of a topical cream used as a drug delivery device for an anti-inflammatory drug. Pharmos stated the test data indicated there were no “severe or serious adverse events” and that the “formulation was safe and well tolerated” in human test subjects. Pharmos applauded … Continue Reading
By Porter Wright on In a recent presentation to FDA, David Rejeski, Director of the Woodrow Wilson Center’s Project on Emerging Nanotechnologies, stated “there are currently 130 nano-based drugs and delivery systems and 125 biomedical devices in preclinical, clinical or commercial development.” Of these, Rejeski identified 77 cancer-related drugs and 56 drug delivery applications. Rejek also stated that the … Continue Reading