Legal & Regulatory

Why outdated paper prescribing information is creating unnecessary cost, complexity and friction across a modern pharmaceutical supply chain.

With a lawsuit, a House delay bill and drugmaker intervention motions in play, here's where HRSA's 340B rebate pilot stands ahead of Jan. 1.

FDA’s final guidance on prescription drug use-related software clarifies when companion app content is labeling, promotion or belongs in the PI.

PhRMA's lawsuit argues CMS overstepped its demonstration authority by tying Medicare Part B rebates to international prices.

HDA's Kala Shankle says a federal licensure baseline could bring real efficiency gains for wholesale distributors and 3PLs, but only if state requirements align and every stakeholder moves on the same timeline.

With HRSA's approval window now closed, attention turns to whether health system pharmacies can reconcile rebates at scale before the pilot's Jan. 1 start.

CMS says 40 states and Puerto Rico have signed on to the GENEROUS Model, which applies MFN pricing to Medicaid drugs through state-invoiced rebates.

The EU's pharma reform makes market protection more conditional. Here is how US drugmakers, especially startups, can adapt and use IP to complement it.

The White House said Medicaid programs in all 50 states, D.C. and Puerto Rico now receive MFN prices, with nearly $65 billion in savings over a decade.

DSCSA data exchange has matured into daily operations, but the coming NDC-12 shift and a national licensure standard add new work streams before old ones are fully settled.

Authenticx CEO Amy Brown on why patient support AI needs continuous oversight, not just adoption.

Twenty-six manufacturers now hold most-favored-nation agreements, and the commitments attached to the pricing terms may matter more than the prices themselves.