FDA opens up electronic communication for companies
This article was originally published in Clinica
The US FDA has updated its practices for communicating with industry to allow device reviewers to respond to companies via fax and email. The March 1 Blue Book Memo, which outlines the changes, says they will provide a "fair and consistent" approach to what the agency says is now the ubiquitous use of electronic communications. It also will help reduce the paperwork burden on industry in the spirit of the much-touted least burdensome provision of the 1997 FDA Modernization Act, the agency said.