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Declaring Victory: How FDA Releases REMS

 
• By Michael McCaughan

There is a new category of FDA action letter: a REMS release. Dozens of sponsors of “MedGuide-only” REMS received them after an FDA policy change. But now, FDA is issuing them regularly to sponsors whose communication plans have met their goals – or at least run their course.

It speaks volumes about the current state of Risk Evaluation & Mitigation Strategies that FDA has released more REMS than it has imposed for each of the past two years.

In the fourth year of the REMS era (April 2011-March 2012), that was a function of a policy changed: FDA concluded that a mandatory Medication Guide no longer automatically requires...

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FDA’s FY 2026 Budget Request Lacks New Policy Proposals

 
• By Sue Sutter

The White House requested $6.8bn for the FDA, down 3.9% from the current funding level, but does not propose any legislative changes. In previous years, the agency used the budget process to seek statutory fixes specific to generic drugs and shortages.

User Fee-Funded Staff Would Drop In FY 2026 US FDA Budget

 
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