'Size Matters,' says FDA, when it comes to generic drug-RLD sameness

In what appears to be a further sign of the US Food and Drug Administration’s efforts to clamp down on differences between brand-name Reference Listed Drugs (RLDs) and their proposed generic counterparts, the FDA’s Office of Generic Drugs (OGD) is now looking more closely at tablet size differences. The increased scrutiny may be intended to address, at least in part, criticism about some generic drugs not acting the same as their brand-name counterparts, notes Kurt Karst, writing on law firm Hyman, Phelps & McNamara’s FDA Law Blog.