GAO says ongoing drug shortages are increasing, but FDA says they are flattening; contrasting definitions of “shortage” produce the disparate results.

House hearing includes arguments that regulatory delays thwart the market’s response to shortage price signals, suggesting reforms could be included in user fee legislation along with the popular early warning requirement.

One of US FDA’s most important publications ever, the Orange Book celebrates 40 years as the definitive guide to approved drug products and therapeutic equivalents. Even as the color has receded from the book itself, orange still generates appreciation from regulators and outside attorneys.