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.
You may also be interested in...
FDA has started implementing changes called for in a draft guidance on labeling of drugs granted accelerated approval throughout the last three-quarters of 2014, without waiting for the final guidance or even the comment period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.
FDA draft proposal could lead providers, patients and insurers to mistakenly believe a drug cleared under the expedited pathway does not meet the same standards as other drugs, PhRMA and BIO say.
Draft guidance calls for a clear statement in the Indications and Usage section of labeling that reflects a drug’s clearance under accelerated approval on the basis of a particular surrogate or clinical endpoint. The document also includes provisions for reflecting the withdrawal of accelerated approval in labeling.