QDIS Blog

Recently the FDA announced they were changing how they review generic drug applications.

FDA Offers Speedy Approval for Some Drugs

Previously, it was first come first serve and applications were held in a que. They were then reviewed, the oldest to the more recent and the median timeframe was about 16 months.

Now however,while still using the FIFO approach, the FDA will prioritize some applications based on “their public health impact”. This sounds good and will indeed help but I’m somewhat hesitant to give it a rousing endorsement. Until I hear more details on what criteria is used, it seems ripe for abuse and/or manipulation. The days of the generic drug scandal are not that far gone and those lessons learned should not be ignored.

I’m hopeful that this will indeed be an improvement but will keep an eye out to see how it is implemented. It should be noted that this will only apply to approximately 25% of the generic applications.

For those interested the 5240.3R Review Order of Original ANDAs, Amendments, and Supplements (pdf) is available online.

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