CMS is sharply limiting the ability of Medicare plans to make formulary changes during a plan year-except when FDA demands a new warning. Though CMS says it doesn't want to interfere with FDA's regulation of drug safety, the policy is likely to complicate the already difficult labeling negotiations over new warnings.
The cost to pharmaceutical companies of adding a new "black box" warning to product labeling just got higher.
A black box, so named because the warning information is highlighted in a box placed at the top of the package insert, is the strictest warning the Food & Drug...
The EU must renew the mandate of its Health Emergency Response Authority to support medicine stockpiles and enable agile manufacturing to combat antimicrobial resistance and chemical, biological, radiological and nuclear threats, says trade organization EUCOPE.
Japan is cutting more drug reimbursement prices following cost effectiveness analysis and is applying the methodology to a new group of products including Wegovy and Leqembi.
