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Opioid Training Syllabus Increases Emphasis On Patient Monitoring In Final REMS Blueprint

 
• By Cathy Dombrowski

Prescriber training courses to be provided through continuing medical education venues are to be available by March 1, 2013. Changes from the draft are subtle, but indicate FDA’s focus on preventing incorrect use of the high-dosage narcotics and protecting patients.

FDA’s final syllabus for a voluntary education program for prescribers of long-acting/extended-release opioids follows the same outline as a draft version but contains more reminders about the abuse potential of the drugs and the need for close patient monitoring.

Sponsors of 35 brand and generic opioids will fund continuing medical education courses based on the syllabus as they implement a class-wide Risk Evaluation and Mitigation Strategy, FDA announced July...

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The FDA is not currently signaling that stringent rules for the process will be relaxed, but the agency's change in approach is notable.

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Safety Review Prompts EMA to Suspend Ixchiq Chikungunya Vaccine For Seniors

 
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Non-User Fee Dollars Increased In US FDA’s Updated FY 2026 Budget Request

 
• By Derrick Gingery

The budget authority total, which is significantly higher than the amount floated in an April OMB draft document, suggests there may have been successful lobbying to increase FDA funding.

US ‘Most Favored Nation’ Pricing Could be Game Changer for Drug Access In Germany

 
• By Francesca Bruce

In this first in a series of articles looking at the potential impact of the MFN drug pricing policy on European pharmaceutical markets, EUCOPE’s Alexander Natz tells the Pink Sheet why the US policy underscores the importance of confidential net pricing.

ICH Targets RWE, Rare Diseases, Biosimilars, ATMPs In New Guideline Push

 
• By Vibha Sharma

The International Council for Harmonisation has identified four new topics that can benefit from global regulatory alignment, with timelines for initiating work to be determined later.