The U.S. Food and Drug Administration (FDA) has published final guidance on “Communications From Firms to Health Care Providers Regarding Scientific Information on Unapproved Uses of Approved/Cleared Medical Products” (SIUU...more
On October 2, 2024, the Centers for Medicare & Medicaid Services (CMS) issued final guidance for initial price applicability year (IPAY) 2027 of the Drug Price Negotiation Program established by the Inflation Reduction Act...more
On May 3, 2024, the Centers for Medicare & Medicaid Services (CMS) issued draft guidance for initial price applicability year (IPAY) 2027 of the Drug Price Negotiation Program established by the IRA. Notwithstanding the...more
Today, the U.S. Food and Drug Administration (FDA) published the draft guidance “Real-World Evidence: Considerations Regarding Non-Interventional Studies for Drug and Biological Products,” which provides recommendations to...more