On 30 June, 2015, new pregnancy labeling rules for prescription drugs took effect, marking the...
FDA consultants take note: expedited development and review programmes have now been used by CDER for more than two decades.
Began in 1992 with accelerated approvals and priority review designation, fast track designation was added in 1997, followed by breakthrough therapy designation in 2012.
Drug development and review processes continue to be streamlined in a way that allows therapies showing early promise to reach patients faster. Not surprisingly, over half of CDER’s 2015 novel drug approvals received expedited review of one type or another.
This latest blog entitled ‘FDA Expedited Development & Review Programmes Explained’ describes each of the expedited programmes in a way that quickly facilitates understanding. Written as a primer for pharmaceutical consulting, the paper is designed to help increase understanding of the expedited programmes, and to aid in distinguishing each from the other."
If you are unsure as to the applicability of these programmes to your drug development programme, when or how to proceed, feel free to download the paper and call PDG.
The US Food and Drug Administration (FDA) would like to accelerate the over-the-counter (OTC) review...