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Pediatric Cancer Studies: US FDA Eyes Waiver Framework For Same-In-Class Drugs

 
• By Sue Sutter

Advisory committee says planned waivers for molecularly targeted studies should take into account comparative adult efficacy and toxicity data for multiple drugs in the same class, as well as differences in product attributes, such as route of administration and dosing schedule; unmet clinical need should have less influence on decision to grant waivers, panelists said.

Framework
US FDA wants to build a transparent framework that it can consistently apply to decisionmaking about pediatric study waivers for cancer drugs. • Source: Shutterstock

The US Food and Drug Administration should take into account comparative efficacy and toxicity data in adults, as well as differences in dosage forms, routes of administration and dosing schedules, when evaluating planned waivers of pediatric studies for multiple same-in-class cancer drugs.

However, the degree of unmet clinical need in a specific pediatric cancer setting should have less influence on whether it...

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More from US FDA Performance Tracker

US FDA’s Second Half 2025 User Fee Goals Swing Toward Respiratory Disease

 
• By Bridget Silverman

The 43 novel agents with user fee goal dates in the remainder of 2025 have fewer oncologics and infectious disease drugs than the first half of the year.

Slowdown: US FDA’s 2025 Novel Approvals Are On Below-Average Pace

 
• By Bridget Silverman

US FDA's 25 novel approvals in 2025 fell short of the agency's five-year average count, driven by a drop in drugs center approvals; 45 user fee goals remain in second half of year.

US FDA’s CRL Release More Incremental Than ‘Radical’ Transparency

 
• By Bridget Silverman

The transparency initiative collects CRLs already made public in approval packages on its drugs@fda site to post on the openFDA public portal.

America Next: Most Novel Agents With July Goal Dates Have Been Approved Overseas

 
• By Bridget Silverman

The US FDA will not be in its usual position as the first regulator to approve novel drugs, with only one of the six novel candidates on the July user fee calendar seeking its first approval worldwide in the US

More from Regulatory Trackers

America Next: Most Novel Agents With July Goal Dates Have Been Approved Overseas

 
• By Bridget Silverman

The US FDA will not be in its usual position as the first regulator to approve novel drugs, with only one of the six novel candidates on the July user fee calendar seeking its first approval worldwide in the US

EU CHMP Opinions And MAA Updates

 
• By Neena Brizmohun

This is an update of recommendations from the European Medicines Agency's Committee for Medicinal Products for Human Use on the authorization of new medicines in the EU, and updates on EU marketing authorization changes recommended by the CHMP.

Global Pharma Guidance Tracker - May 2025

 
• By Vibha Sharma and Anabel Costa-Ferreira

Stay up to date on regulatory guidelines from around the world with the Pink Sheet’s Guidance Tracker. The complete Global Pharma Guidance Tracker, with sortable and searchable listings going back to 2014, is available online.