FDA Expedite Programs: A Complete Overview

With the experience of so many years, one can say that even the most experienced drug development and pharmaceutical consultants cannot give a clear definition of FDA’s four expedited programs, which include approval acceleration, review of the priority, fast track, and break-through therapy. The FDA issues drug approvals only after the review. FDA Expedite programs or review programs are the terms that come from guidance. 

It is a supposed misconception that the orphan drug program is also included in one of the expedited programs, but it is not in reality. The fast approval mechanism was brought into existence to help patients in dire need suffering from different forms of serious diseases. The main objective of accelerated approval is to get a proper review from the candidates suffering from a severe condition and undergo specific therapies. So to get approval, which is accelerated, sponsors need to submit their application to the FDA. And to accept the application for approval, two primary tests are applied:

What one means with the severe conditions? If one patient suffers from any disease that that very disease becomes a serious condition irrespective of everything. The serious condition means it significantly influences one’s movement and affects an individual’s daily activity. 

Clinical judgment decides and determines whether a disease is severe or not. It may happen that if the proper treatment is not given to the patient, then the condition can become so serious that it may lead to the death of the patient. It provides an overall idea of surrogate endpoints, which says how the patient responds to the given medications and the recovery rate of an individual.

It means that specific diseases may not have proper diagnosis and treatment until now, like cancer, which needs the doctors’ utmost care and attention. Sometimes a particular therapy or a diagnosis can make the condition less severe but cannot fully eradicate the present condition as approved by the FDA. Some intermediate points can be measured on immutable morbidity and can also predict the drug’s effect on IMM or any other similar clinical advantage.

It may happen that for accelerated FDA approval, sponsors may do anything, so to ensure proper quality, there are pre-qualification eligibility criteria appended like sponsor should discuss every detail with the FDA Expedite programs about the very intention of the request of the approval at the early stages of the development of the drug.  This request could help the sponsor to be able to choose the best surrogate points during all the phases of clinical trials. 

CDER has been using FDA Expedite programs for a long period. It is a matter of the fact that these two facets of expedited programs are the applications of serious diseases and the consultation for early approval by the FDA. The development of the drug and the review of the various processes have been narrowed down to ensure that the following therapies reach the patient as soon as possible. 

A point that is to be noted is that their use has been increasing exponentially; moreover, half of 2015 CDER approval of novel drug has received expedited reviews of all types. If one is unsure of the applicability of the ongoing expedited programs of the drugs’ development, then one may call PDG for any further information as and when needed.

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