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Generic drugs to be scored based on risk.
Addressing the Generic Pharmaceutical Assn. technical conference in Washington Oct. 25, OGD officials outlined their QBR program, which they hope will cut down on reviewer time and questions.
Under QbR, companies will provide the answer to reviewer questions to save FDAers time in looking at applications.
In addition, FDA is going to try to reduce the number of changes being effected (CBE) supplements and prior approval supplements using a new scoring system to determine the risk of a product.
Radhika Rajagopala, Ph.D., special assistant in OGD, said the number of ANDAs has mushroomed in her office, while the number of employees has remained constant--from about 300 applications and 180 staffers in 2001 to about 800 ANDAs and 200 employees in 2005.
Chemistry supplements have become even more burdensome. She said the office now is receiving 3,534 original chemistry applications and 3,177 supplements, up from 2,767 and 2,566, respectively, in 2004.
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