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Welcome from
Director, Office of Generic Drugs
Gary Buehler
The Office of Generic Drugs (OGD), part of FDA’s Center for Drug Evaluation and Research is staffed by over 230 highly skilled review scientists, physicians, pharmacists and support staff. The staff is dedicated to approving safe, effective, high-quality and bio-equivalent generic drug products for use by consumers.
The American public can be confident that when a generic drug product is approved, it has met rigorous standards established by the FDA with respect to identity, strength, quality, purity and potency. Through review of bioequivalence data, OGD assures that the generic product will perform the same as its respective brand name (or reference) product. In addition, all generic manufacturing, packaging and testing sites must pass the same quality standards as those of brand name drugs and the generic products must meet the same exacting specifications as any innovator product. In fact, many generic products are made in the same plants as innovator drug products. Generic drugs provide Americans with safe and effective alternatives to brand name prescription drug products.
In recent years, the number of applications for new generic products has continued to escalate from 563 in FY2004 to 880 in FY 2007. In spite of the greater workload, OGD has taken increasing numbers of approval actions on applications – 413 in FY 2004 to 682 in FY 2007. You can keep up-to-date with recently approved generic products by going to the “What’s New” section of our site.
The greater numbers of generic applications has been a challenge for the Office of Generic Drugs review staff. We have been diligent in finding ways to streamline the review process. One important approach, announced by Commissioner von Eshenbach in October of 2007, is the Generic Initiative for Value and Efficiency (GIVE). This provides a framework for focusing our existing resources to help modernize and streamline the generic approval process. We have also engaged in a focused hiring process to assure OGD has adequate numbers of highly qualified, top-notch scientists and clinicians. Training of new staff is proceeding well and we look forward to another year of record approvals.
Please take time to peruse our site and learn more about the science of approving generic drug products.
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Date updated: April 9, 2008 |
