Draft Guidance for Industry on Labeling for Human Prescription Drug and Biological Products Approved Under the Accelerated Approval Regulatory Pathway

The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled "Labeling for Human Prescription Drug and Biological Products Approved Under the Accelerated Approval Regulatory Pathway."
This draft guidance discusses FDA's recommendations for developing the indication and usage statements in the prescribing information for drugs approved under the accelerated approval regulatory pathway (hereafter "accelerated approval"). It also discusses labeling considerations for indications approved under accelerated approval when clinical benefit has been verified and FDA terminates the conditions of accelerated approval (PMPNews.com, 26 March 2014).
Click here for the original news item.
Click here to download the draft guidance (170 kB).

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