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FDA’s Upcoming Drug/Diagnostic Co-Development Guidance Could Quickly Become Outdated

Tests that look for many markers at a time “may completely change” the paradigm for companion diagnostics, CDRH’s Elizabeth Mansfield says.

FDA is almost done writing a draft guidance on how to co-develop a companion diagnostic for a drug, but the document could essentially be outdated as soon as it is released.

The co-development draft guidance will address the types of issues drug and diagnostics firms should consider as they develop paired products, such as when tests should be incorporated into clinical trials. The document is based on what the agency has learned from drugs and companion diagnostics that have already gone through the approval process, according to Elizabeth Mansfield, director of personalized medicine at FDA’s device center, during an Oct. 28 press briefing to discuss an FDA

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Access To Library Tools Being Restored At US FDA

 
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Agency staff once again have access to the Lexis-Nexis legal and news database, but are still waiting for access to journals and laid off librarians have not been reinstated.

FDA Announces Classifications On 9 Device Types

 
• By Elizabeth Orr

The US Food and Drug Administration has announced new classifications for eight device types that reached market via the de novo process, with most of the newly classified products in the diagnostics sector.

Medical Devices Not The Focus Of FDA’s Plans To Step Up Foreign Inspections, Expert Says

 
• By Brian Bossetta

The US FDA recently announced plans to carry out more unannounced inspections of foreign facilities. But those inspections will primarily target drug producers, with less attention and resources allocated to those making devices.