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Shortage Notification May Have Legislative Momentum Again After BIO Questions Reimbursement Fix

 
• By Derrick Gingery

Preventing shortages through increased communications with manufacturers could gain the upper hand in part because creating economic incentives may prove too difficult and controversial.

The needle in congressional efforts to fight drug shortages may have swung back toward enhanced communications after several weeks pointing to economic incentives, indicating efforts by FDA and others are paying off.

A draft bill by Rep. John Carney, D-Del., that would create lists of critical drugs in shortage as well as...

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More from United States

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More from North America

US FDA Approves First Reformulated Rx Ranitidine, Five Years After Withdrawal

 
• By Malcolm Spicer

The FDA included storage and handling instructions common in labeling in its approval announcement, suggesting concerns remain about the potential for NDMA to form after products are distributed.

As US FDA Turns: Can Makary, Prasad And Pazdur Make It Work?

 
• By Michael McCaughan

The FDA leadership drama continues after Richard Pazdur was elevated to drug center director. Can Pazdur, CBER Director Vinay Prasad, and Commissioner Martin Makary get along?

Obscure User Fee Provision Gives Generic Drug Sponsors More Time To Pay Fees Post-Shutdown

 
• By Derrick Gingery

ANDA sponsors received 20 days to pay fees associated with applications submitted during the government shutdown, while NDA and BLA sponsors only received five days.