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“Breakthrough” Designation: FDA Clarifies How To Get It – And How It Can Be Lost

 
• By Sue Sutter

“Preliminary clinical evidence” should demonstrate substantial improvement in effectiveness or safety over available therapies but likely will not be sufficient to support approval, final guidance explains.

FDA’s final reference document on expedited regulatory pathways clarifies several aspects of the “breakthrough therapy” program, including the types of “preliminary clinical evidence” that would support a designation.

The guidance, “Expedited Programs for Serious Conditions – Drug and Biologics,” defines what the agency means by preliminary...

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More from United States

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US FDA Upheaval Forces User Fee Talks To Begin Later Than Usual

 
• By Derrick Gingery

The fall start of PDUFA and GDUFA negotiations could impact the agreement review process and other parts of the schedule intended to ensure it reaches Congress on time.

Vanda Slams US FDA ‘Generic Bias,’ Again Seeks To Undo Hetlioz ANDA Approvals

 
• By Dave Wallace

In its latest attempt to curtail generic versions of Hetlioz, Vanda Pharmaceuticals asked FDA Commissioner Martin Makary to reverse a previous agency decision upholding two ANDA approvals, claiming an “unacceptable culture of bias toward approving generic drugs” at the agency.

Pink Sheet Podcast: US FDA Changes COVID-19 Vaccine Labeling, Reimbursement Confusion Rises

 
• By Derrick Gingery, Sarah Karlin-Smith, and Sue Sutter

Pink Sheet reporter and editors discuss the US FDA’s changes to the COVID-19 vaccine indication and its revocation of the vaccine emergency use authorizations, as well as new vaccine coverage and reimbursement questions.

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