FDA Call For Pediatric Cough/Cold Input Signals New Rule Is A Long Way Off

FDA plans to revise monograph language for over-the-counter pediatric cough/cold products, but the agency is seeking input on some basic data questions first, indicating many steps will be taken before a rule can be finalized

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Brazil To Upgrade Pricing Framework To Keep Up With Market Developments

 

Brazil plans to clarify its medicine pricing framework, for example by outlining the procedures for setting medicine prices and bring it up to date with recent developments in the sector.

England: HTA Sandbox Helping To Assess ‘Challenging’ Drugs And Indications

 

England’s health technology assessment institute explains how its sandbox environment is helping to test new evaluation methods for drugs or indications with which it does not have experience, such as metabolic dysfunction-associated steatohepatitis.

Unlocking Opportunities: How To Engage With The EMA On Animal Testing Alternatives

 

The European Medicines Agency, like its counterpart in the US, is increasingly focusing on the use of alternatives to animal testing.