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US FDA Pushes Back Against Critics: Breakthrough Is Not A Drug 'Beauty Contest'

 
• By Derrick Gingery

Richard Pazdur, FDA's oncology chief, reiterates the breakthrough therapy designation is for agency-sponsor communication and not an investor tool.

FDA's Richard Pazdur speaks during a Capitol Hill briefing sponsored by the Friends of Cancer Research. • Source: Sue Darcey

The US Food and Drug Administration and the oncology community are pushing back against concerns that the agency's breakthrough therapy designations convey lower approval standards on the products that receive them. 

With drug pricing and access to therapies a popular issue and payers not immediately offering reimbursement for some FDA-approved therapies,...

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AI And Inertia: The Disruptors Keeping EU Regulators Awake At Night

 
• By Francesca Bruce

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China Unveils Multiple Policies To Support Innovative Drugs Throughout Life Cycle

 
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