Communications between the FDA and the biopharmaceutical/medical device industry have significantly improved, but the relationship is still strained by unnecessary approval
delays, according to a survey by the University of California at San Diego and PricewaterhouseCoo-pers. The study, first conducted in 1995, tracks the non-science-based factors
that delay the FDA approval process. Survey respondents were U.S. companies that had a drug device or biologic in clinical trials under the FDA's supervision between Jan. 1, 1998
and June 30, 1999.
Overall, 48% of biopharmaceutical/medical device companies categorized their communications with the agency as "excellent," up from 41% in 1997 and 34% in 1995. However, 27%
indicated that the lack of a reviewer's technical expertise unduly delayed the approval process, up from 21% in 1997 and 18% in 1995.
Other findings include:
- 64% of respondents said that on average agency reviewers responded to their inquiries within five days, which is up from 52% in 1997 and 45% in 1995.
- 64% said it was easy or very easy to contact the reviewer, up from 52% in 1995. (PricewaterhouseCoopers, http://www.pwcglobal.com)