A survey of the working relationship between the life science industry and the FDA
Since 1995, PricewaterhouseCoopers has periodically surveyed the life sciences industry on its working relationship with the FDA (US Food and Drug Administration). Other surveys were conducted in 1997 and 1999. Previous surveys focused on issues relevant at the time, including:
- Factors that delay or impede the product approval process
- State of communications between the Agency and the life sciences companies
- Factors that influence companies to seek approval and/or manufacture abroad
In this installment of the survey the structure was changed to provide a broad perspective on industry interactions with the three FDA centers. This 2006 update was designed to:
- Be a useful tool for providing constructive feedback to the FDA
- Offer a foundation for an ongoing dialogue between industry and the Agency
We trust that this report will help bring greater understanding of the working relationship between FDA and the life sciences industry and continue the improvements that have been made to date in the regulatory review process.
The report was co-developed by the PricewaterhouseCoopers pharmaceutical industry group and BIOCOM.
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