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REMS Standardization Could Help Opioid Education Efforts

 
• By Derrick Gingery

FDA hopes to begin accepting Risk Evaluation and Mitigation Strategy documents in structured product labeling format later this year.

FDA is hoping to begin the transition to a more standardized REMS format in the coming weeks.

The agency wants to begin accepting REMS documents in structured product labeling (SPL) format this summer, Adam Kroetsch, an operations...

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US FDA May Consolidate Support Services After Extensive Cuts

 
• By Derrick Gingery and Sue Sutter

Commissioner Martin Makary told staff that plans are being developed to centralize HR, IT, travel and other functions, which were heavily impacted by the 1 April reduction-in-force.

US FDA’s Rising First-Cycle Complete Response Rate Draws Congress’ Attention

 
• By Sue Sutter

The House Appropriations Committee wants an analysis of how issues that led to CRLs could have been resolved within the first review cycle and seeks an agency crackdown on counterfeit GLP-1 agonists.

Crisis Or Opportunity? US MFN Policy Could Test Japan’s Appetite For Reforms

 
• By Lisa Takagi

While the adoption of most favored nation drug pricing in the US stands to affect Japanese biopharma firms now heavily reliant on this market, it might also present an opportunity for pricing and policy reforms at home.