Skinny label in Brazil: drug authority seeking to implement new regulations
The Brazilian healthcare legislation establishes in the legal definitions of generic drugs (article 3, items XX and XXI, Statute #6,360 of 1976[1]) that their labels must have all and the same therapeutic indications of the reference-listed drug. The law only allow differentiation in characteristics like product’s size and shape, shelf life, package, and excipients[2]. The…