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Explaining US FDA Development and Review Programmes

A primer for pharmaceutical consultants, our latest blog describes the characteristics, similarities, differences and applicability of each of FDA’s expedited development and review programmes.

Included are discussions of accelerated approval, priority review designation, fast track designation, and breakthrough therapy designation as well as rolling review. It is important to note that two common elements of FDA’s expedited programmes are their applicability to serious disease only, and the need for early consultation with the agency.

Early attention to regulatory strategy is critical as the programmes frequently overlap and it is not unheard of for drug development programmes to make simultaneous use of three or four of them. For example, a breakthrough therapy drug can receive a priority review and an accelerated approval as part of its pathway to FDA approval.

Not surprisingly, in cases where a request for expedited programme designation was denied by FDA, the sponsor often didn’t understand the type of evidence FDA sought. Examples have included such basic oversights as lack of patient data in e.g. applications for breakthrough therapy designation, foregoing FDA ability to determine to substantial improvement.

To learn more about FDA’s expedited programmes and their potential application to your drug development programme, click here to download ‘FDA Expedited Development & Review Programmes Explained’ and feel free to call PDG.

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Pharmaceutical Development Group (PDG) is a drug and medical device consultant that continuously engages in meetings and interactions with the US Food and Drug Administration...
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