6/9/2008

Revisions to the FDA's process of approving proprietary brand names for new drugs could slow the process and lead to more rejections, drug companies said during a two-day meeting to review how the new program might work. Some executives said the new program would require sponsors to do a lot of extra work without any guarantees that the FDA would agree with their conclusions. However, one FDA official said the new process could increase transparency and predictability.

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