Companies want quicker turnaround from FDA

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While acknowledging improvements in the guidance they get from the FDA, the nation's pharmaceutical, biotechnology, and medical device companies still want faster turnaround times and other improvements.

According to results of a study by PricewaterhouseCoopers and Biocom, faster turnaround times were cited by 81% of all respondents as the area in which FDA improvement is most needed.
Results of this fourth survey found that FDA staffing shortages and turnover are the biggest ongoing issue. Some 61% of the firms surveyed agreed or strongly agreed that FDA personnel changes resulted in a break in continuity in at least one of their reviews.

Companies indicated a belief that FDA reviewers still cannot keep pace with reviews. More than half of respondents said goal timeframes have caused the agency to reject products simply because reviewers ran out of time to resolve issues. A minority of companies reported that FDA changed its position during product reviews, allegedly for no discernible scientific reason.

“This study is very important because the working relationship between the life sciences industry and FDA has a critical bearing on the health of Americans,” said Biocom president Joseph Panetta. “The good news is that these relationships have greatly improved since enactment of the Food and Drug Administration Modernization Act of 1997.”

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