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A study released by Southern California life sciences trade group BIOCOM and PricewaterhouseCoopers said staffing shortages, turnover and product review delays at the U.S. Food and Drug Administration are causing challenges for the industry. According to the survey of 66 drug, biologic product and medical device companies, 61% of respondents cited turn-around times as the area where the FDA needs the most improvement. The same percentage agreed or strongly agreed that FDA personnel upheaval affected at least one of their product reviews. Survey respondents also acknowledged that they might be contributing to some problems with the agency. One-half of life science firms overall and 62% of the surveyed life science firms said they’re not using the agency’s feedback in product development. Despite the concerns, 81% said the agency has improved significantly, since the Food and Drug Administration Modernization Act of 1997 and 70% said their company’s working relationship with the agency is also better. The Improving America’s Health IV survey updates similar PricewaterhouseCoopers studies in 1995, 1997 and 1999.

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