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Alzheimer’s And Surrogate Endpoints: FDA’s On A Case-By-Case Basis Per New Guidance

 
• By Sarah Karlin-Smith

After Aduhelm and Leqembi rendered the 2018 guidance moot, FDA formally acknowledges the possibility of using surrogate endpoints for accelerated approval in Alzheimer’s in updated draft but says acceptability of the any endpoint will depend on details of specific therapeutic program.

Alzheimer disease as a neuropathology memory loss due to brain degeneration and decline as a surreal medical neurology illness concept.
• Source: Shutterstock

The US Food and Drug Administration is retrospectively endorsing the possible use of surrogate endpoints for accelerated approval in early Alzheimer’s disease in new draft guidance, but it isn’t giving any surrogate –including amyloid beta – a universal endorsement.

This means sponsors will still need to check in early with FDA to get some confirmation about their approach to...

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Prasad’s Return Shelves Center Consolidation, But Maybe An Opening For OCE 2.0?

 
• By Kate Rawson

Vinay Prasad’s exit from the US FDA reignited conversations about integrating its drugs and biologics centers under George Tidmarsh. Those plans appear to be shelved, but the leadership transition could be an opportunity to fully realize the vision for the Oncology Center of Excellence.

Prasad 2.0 Brings New Instability Concerns, Questions About Changed Regulatory Philosophy

 
• By Sarah Karlin-Smith

Many agency stakeholders believe Vinay Prasad may be forced to change his regulatory approach at least somewhat after receiving a second chance to lead the US FDA's biologics center.

More Telework, More Staff, US FDA’s Tidmarsh Plans To Alleviate Workforce Challenges

 
• By Sarah Karlin-Smith

The new CDER director focused on plans to improve morale during an Aug. 8 townhall, but staff comments indicate that may be a challenge.

New US FDA CDER Director Pledges No Politics In Approvals, Adds Higher Ups Can Overturn

 
• By Sarah Karlin-Smith

New CDER Director George Tidmarsh promised to keep politics out of drug approvals, but suggested during a meeting with staff that he could not insulate the drug center from political pressures coming from those above him.

More from Agency Leadership

New US FDA CDER Director Pledges No Politics In Approvals, Adds Higher Ups Can Overturn

 
• By Sarah Karlin-Smith

New CDER Director George Tidmarsh promised to keep politics out of drug approvals, but suggested during a meeting with staff that he could not insulate the drug center from political pressures coming from those above him.

US FDA Requires Opioid Class Labeling Changes Despite Adcomm Advice

 
• By Kate Rawson

Quantitative estimates of the safety risks with opioid pain medication, including the risk of addiction and misuse, must be added to labeling.

US FDA Skips User Fee Increase For More Staff Amid Exodus, Hiring Difficulties

 
• By Derrick Gingery

A calculation used to determine whether the FDA has the staff to handle its workload also was not included in the description of prescription drug user fee calculations.