On 19 December 2016, the European Medicines Agency (“EMA”) published an updated version of the EMA guidance document concerning post-authorisation procedural advice for users of ...24 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.
Regulation (EU) No 536/2014 of 16 April 2014 on clinical trials on medicinal products for human use, and repealing Directive 2001/20/EC (“the Clinical Trials Regulation”) was...24 January 2017
The UK Medicines and Healthcare products Regulatory Agency (“MHRA”) has published a draft strategy for developing pharmacopoeial public quality standards for biological...20 January 2017