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US FDA’s Streamlined Drug Approval Packages Shine Less Light On Sponsor Interactions

 
• By Sue Sutter

CDER is no longer proactively posting mid- and late-cycle meeting minutes and certain correspondence with sponsors for new drug and biologic approvals; drugs center says it is focused on ensuring the most scientifically meaningful information is prioritized and posted in a timely manner, but some observers say the change raises transparency concerns.

hand open curtain - concept of change and reveal new better world
FDA's drugs center is not pulling back the curtain on new drugs reviews quite as much as it used to.

The US FDA’s Center for Drug Evaluation and Research (CDER) is proactively releasing less information about the drugs and biologics it approves in the name of faster disclosure of the most important details about its reviews.

The drugs center has stopped posting to its website certain correspondence and minutes of meetings with sponsors about approved new drug applications (NDAs) and biologics license applications (BLAs), including mid-cycle...

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