Medtech Insight is part of Informa PLC

This site is operated by a business or businesses owned by Informa PLC and all copyright resides with them. Informa PLC’s registered office is 5 Howick Place, London SW1P 1WG. Registered in England and Wales. Number 8860726.

This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

Printed By

UsernamePublicRestriction
UsernamePublicRestriction

FDA opens up electronic communication for companies

This article was originally published in Clinica

Executive Summary

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.

Advertisement

Topics

Advertisement
UsernamePublicRestriction

Register

MT065087

Ask The Analyst

Please Note: You can also Click below Link for Ask the Analyst
Ask The Analyst

Your question has been successfully sent to the email address below and we will get back as soon as possible. my@email.address.

All fields are required.

Please make sure all fields are completed.

Please make sure you have filled out all fields

Please make sure you have filled out all fields

Please enter a valid e-mail address

Please enter a valid Phone Number

Ask your question to our analysts

Cancel