What Is GIVE
What is GIVE?
Generic Initiative for Value and Efficiency or GIVE is an initiative by the Food and Drug Association to bring in more generic drug products to the markets so that they can make cheaper drugs more wide spread to the public.
Its purpose is to get higher numbers of applicants and give priority drugs because there are fewer generics available.
In order to make this happen, the FDA needs to streamline the regulatory and approve the process in order to keep getting more applications and regulate pharmaceutical companies and more efficiently keep higher standards.
It is important because the increasing volume of applications and the expansion of the association and the workload that has picked up over the years due to the rate of the advanced medical science.
An interview with GIVE and their Direction of the Office of Generic Drugs Mr. Buehler, RPH, said that this was going to be achieved.
Q: How will the goals of GIVE happen?
A: GIVE will work by combining our offices different efforts into one harmonized activity to implement process improvements through the entire program. The initiative is to review oriented programs that are focused on three main ideas:
- Mobilizing staff effort to increase review productivity.
- Optimizing the capacity and capability of all assets within OGD and leveraging wherever possible resources from FDA components.
- Using every possible place to recruit and hire reviewers for the critical care needs of patients.