FDA's Draft Guidance on Accelerated Approvals and the Impact on Biotech Free Video

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"FDA's Draft Guidance on Accelerated Approvals and the Impact on Biotech"

Free Video: "FDA's Draft Guidance on Accelerated Approvals and the Impact on Biotech"

In the recent draft guidance on accelerated approval pathways, the FDA emphasizes heightened requirements for confirmatory trials and introduces a new process for expedited withdrawal of approval, establishing stricter requirements that biotechs must meet to maintain their accelerated approvals.
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"FDA's Draft Guidance on Accelerated Approvals and the Impact on Biotech"

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