How to Successfully Respond to an FDA Information Request (IR)

By Modality Solutions

The US Food & Drug Administration (FDA) strives to review and act on applications within ten months for standard review or six months for priority review, but that doesn’t mean you won’t hear from them in the interim.

It’s common for the FDA to issue an Information Request (IR) during its review cycle and it’s critical that you respond quickly and effectively to get your vaccine or therapeutic approved in a timely way.

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