Concept richtsnoer voor industrie over etikettering van geneesmiddelen voor mensen en biologische producten goedgekeurd via 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The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled "Labeling for Human Prescription Drug and Biological Products Approved Under the Accelerated Approval Regulatory Pathway." This draft guidance discusses FDA's recommendations for developing the indication and usage statements in the prescribing information for drugs approved under the accelerated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 maart 2014).
Klik hier voor het oorspronkelijke nieuwsbericht.
Klik hier om het concept richtsnoer te downloaden (170 kB).

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