GIVE
April 14th, 2008
GIVE
Generic Initiative for Value and Efficiency or GIVE is an initiative by the Food and Drug Association to bring more generic drug products to the market in order to make safe cheap generic drugs more widely available to the public.
Its aims are approve higher numbers of applications and give priority to drugs for which there are few generics available.
In order to do this the FDA need to streamline the regulatory and approvals process in order to process more applications and regulate pharmaceutical companies more efficiently whilst still maintaining high standards.
This is necessary due to the increasing volume of applications and consequent expansion of the association and its workload in recent years due to the rate of advancement in medical science.
In an interview on GIVE the Director of the Office of Generic Drugs Mr Buehler, RPh., stated how this was to be achieved.
Q: How will the goals of GIVE be accomplished?
A: GIVE will work by combining our office’s various efforts into one harmonized activity to implement process improvements throughout the entire program. The initiative is a review-oriented program that is focused on three main areas:
- Mobilizing staff efforts to increase review productivity.
- Optimizing the capacity and capability of all assets within OGD, and leveraging wherever possible resources from other FDA components.
- Using every avenue possible to recruit, hire and train reviewers for our critical-need areas.
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