Non-binding Guidance: Expedited Review Programs for Drugs and Biologics

Non-binding Guidance: Expedited Review Programs for Drugs an...

Non-binding Guidance

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The fifth installment of Ropes & Gray’s podcast series, Non-binding Guidance, is the first part of a two-episode discussion of FDA expedited review programs. In this episode, Ropes & Gray lawyer Greg Levine interviews his partner Kellie Combs, who provides an overview of the four expedited review programs for drugs and biologics: the Fast Track, Breakthrough Therapy, Priority Review, and Accelerated Approval programs. These programs, which are br...
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The fifth installment of Ropes & Gray’s podcast series, Non-binding Guidance, is the first part of a two-episode discussion of FDA expedited review programs. In this episode, Ropes & Gray lawyer Greg Levine interviews his partner Kellie Combs, who provides an overview of the four expedited review programs for drugs and biologics: the Fast Track, Breakthrough Therapy, Priority Review, and Accelerated Approval programs. These programs, which are br...
Read More