The UK Medicines and Healthcare products Regulatory Agency (“MHRA”) has published guidance for companies submitting a Manufacturing Authorisation application or variation on...06 January 2017
FTC Requires Two "Gold-Standard" Studies in Sketchers Consent Decree
Notably, the consent decree entered into by Sketchers requires the company to have at least two well-controlled human clinical studies to substantiate weight loss claims. The Sketchers case is the most recent example of FTC’s pattern of implementing the potentially more stringent requirement of two placebo-controlled, double-blind clinical studies as substantiation for health-related claims (the so-called gold standard), rather than the traditional standard of “competent and reliable evidence.” Interestingly, FTC’s order in the Reebok case only required one gold-standard study. Although FTC has stated that it is not requiring two clinical studies as a blanket substantiation standard, the Sketchers case provides another example of the types of claims FTC views as requiring a more precise level of support.
On 16 December 2016, the European Medicines Agency (“EMA”), along with the European Biopharmaceutical Enterprises (“EBE”) organised the fifth annual regulatory...03 January 2017
On 8 December 2016, the European Medicines Agency (“EMA”) organised a workshop in collaboration with the European Commission to gather the views and proposals from stakeholders...03 January 2017