Accelerated Approval Labeling Changes Take Shape In Recent Approvals
FDA has started implementing changes called for in a draft guidance on labeling of drugs granted accelerated approval throughout the last three-quarters of 2014, without waiting for the final guidance or even the comment period to close.
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Accelerated Approval: US FDA Labeling Guidance Calls Out Surrogate Endpoints Needing ‘Additional Context’
For Indications and Usage section of some drugs, such as anti-cancer agents, it may be enough merely to state that accelerated approval was based on a specific surrogate; however, labeling for other types of drugs may need to reflect the clinical outcomes that are expected but not yet established, agency says.
In an unusual move, industry rep indicates comfort with draft guidance implementing biosimilar pathway.
US FDA must rethink guidance on maintaining placebo-control in COVID-19 trials after any vaccine gets an EUA, companies say, arguing current proposal may not be ethical or feasible. Disease organizations who agree with the hurdles to preserving placebo-control maintain this is a reason why any EUA must meet a very high standard.