PwC: FDA gets better grade for guidance, flunks review

PricewaterhouseCoopers took the drug development industry's temperature on its often turbulent relationship with the FDA and found it running high over some frequently mixed regulatory signals. But most of the 50 biopharma companies surveyed by the big accounting firm also found that the agency is getting better scores for providing clear guidance on regulators' expectations.

Altogether more than a third of the life sciences companies said that their relationship with the agency had improved in the last two years while eight in 10 noted that the FDA was offering better guidance on their development programs. But six in 10 claimed that regulators had shifted positions during a review and four in 10 felt that products were rejected due to the FDA's inadequate resources. Most don't feel the agency is keeping up with technology and only eight percent say the agency is doing enough to advance the personalized medicine trend.

There was also a palpable sense of dismay, with close to half of the companies saying that higher fees haven't done anything to accelerate the regulatory process.

"Clearly there is a need for better communication between FDA and the industry over the intended use and effectiveness of user fees," said Joseph Panetta, president and CEO of BIOCOM, which helped with the survey. Thirty percent of the companies felt the user fees are excessive considering the time the agency takes.

- check out the PwC release for more info

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