May 23, 2007
FDA improving, needs work, say science cos.
By Matthew L. Brown
According to a new PricewaterhouseCoopers LLP study, the nation's pharmaceutical, biotechnology and medical device companies think the U.S. Food and Drug Administration has improved its guidance, expectations and approval process.
But product review delays and a long approval process are still problems.
The FDA is providing better guidance and clearer expectations to applicants, according to 73 percent of companies questioned for the study.
Those companies say the FDA's fast track program works, and eight out of 10 life sciences companies said the administration has made significant improvement in that regard.
The study also found that companies' working relationships with the FDA have greatly improved.
But some companies complained that the FDA had changed its position for no reason during the review of product submissions.
Companies also thought FDA staffing shortages and employee turnover "remain the biggest ongoing issue for life sciences firms," according to the study.
FDA reviewers are unable to keep pace with reviews, and life sciences companies said the FDA's user fees have not worked to reduce approval times.
But product review delays and a long approval process are still problems.
The FDA is providing better guidance and clearer expectations to applicants, according to 73 percent of companies questioned for the study.
Those companies say the FDA's fast track program works, and eight out of 10 life sciences companies said the administration has made significant improvement in that regard.
The study also found that companies' working relationships with the FDA have greatly improved.
But some companies complained that the FDA had changed its position for no reason during the review of product submissions.
Companies also thought FDA staffing shortages and employee turnover "remain the biggest ongoing issue for life sciences firms," according to the study.
FDA reviewers are unable to keep pace with reviews, and life sciences companies said the FDA's user fees have not worked to reduce approval times.
WBJ Web Partners
Most Recent
0 Comments