Plan addresses submission decline

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FDA says it is banking on its regulatory science initiative to reverse a decline in new drug and biologic submissions and approvals seen over the past few years.
Addressing a Drug Information Association Webinar on regulatory science in January, FDA senior advisor for science, innovation and policy Vicki Seyfert-Margolis said the agency is worried about the downward trend.
New drug and biologic submissions for 2010 sank to the lowest level seen in 15 years—only 26 new drug application and biologic license applications were submitted last year when the average over the past five years has been 32 submissions per year.
Seyfert-Margolis said regulatory science is now being geared to help “de-risk” the drug development process and to identify those key points that are contributing to a decline in the medical product pipeline.
Some examples of projects planned for this include the continuing advancement of genomic-based technologies and high throughput screening tools, both in the area of predictive toxicology and tailored therapies, where genetic or other information helps to select those patients who respond.
Another involves the use of clinical biomarkers which can decrease costs by identifying better responders, reduce trial sample sizes, exclude patients early with the use of toxicity biomarkers, shorten end-point observation times, and allow educated data mining, she said.

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