Drug pricing presents intriguing political dynamics. Whether and what policy prescriptions actually come to fruition in the next two years remain to be seen, but the rhetoric around the imperative to lower drug pricing — and the political pressure to act — will be more intense than we have seen to date. President Trump and … Continue Reading
Over the past months, the Government has regularly posted technical guidance notices on what it calls a “no deal” Brexit, i.e., a scenario in which the UK and the EU will not reach an agreement and the UK will become a third country on 29 March 2019. The UK Government has now published four notices … Continue Reading
In October 2014, the Nagoya Protocol entered into force. It created a new international regulatory system affecting all life science companies that conduct R&D on biological material such as animals, seeds, flowers, viruses, fragrances, flavonoids, essential oils, enzymes, yeasts, and so on. So far, compliance by companies is progressing slowly due to unawareness of the … Continue Reading
The post-election period — from the lame duck congressional session to the first 100 days and beyond of a new Administration and Congress — is expected to be a time of extraordinary, if not unprecedented, public policy debate on issues that impact pharmaceutical/life sciences companies and interest groups. These issues present both significant threats and … Continue Reading
China’s legislature, the National People’s Congress (NPC), has released a draft of the revised Food Safety Law (Draft FSL) for public comment. The comments are due on July 31, 2014. The Food Safety Law was last revised in 2009, when the government changed the Law’s name from the Food Hygiene Law and altered most of … Continue Reading
On June 24, 2014, the Food and Drug Administration (FDA) released three final guidance documents addressing the agency’s general approach to nanotechnology and its use by the food and cosmetics industries, as well as a draft guidance on the use of nanomaterials in food for animals. These guidance documents reflect FDA’s understanding of nanomaterials as … Continue Reading
