"In most cases" a MedGuide would be included as part of a REMS only when elements to assure safe use are needed, the agency says in a draft guidance.
Join thousands of industry professionals who rely on Pink Sheet for daily insights
Already a subscriber?
Cuts to the FDA’s policy and legal personnel have prevented dozens of product-specific guidances for generic drug development from being published.
The Oncologic Drugs Advisory Committee will meet for two days in mid-May, followed by a Vaccines and Related Biological Products Advisory Committee’s review of the 2025-2026 COVID-19 vaccine formulation.
Brazil plans to clarify its medicine pricing framework, for example by outlining the procedures for setting medicine prices and bring it up to date with recent developments in the sector.
