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April 14th, 2008

April 14th, 2008

April 14th, 2008


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

– 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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