Companies fear delays in FDA approval of brand names

06/8/2008 | RPM Report (free registration), The

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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RPM Report (free registration), The

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