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

Industry Should Prefer Early Collaboration "Agreement" Meetings - Alpert

This article was originally published in The Gray Sheet

Executive Summary

FDA's propensity to suggest that sponsors hold non-binding "agreement" meetings in lieu of binding "determination" meetings in their pursuit of agency go-ahead is in industry's best interest, Susan Alpert, director of the Center for Devices and Radiological Health's Office of Device Evaluation, maintained.
Advertisement
Advertisement

Related Content

Advertisement
UsernamePublicRestriction

Register

MT012432

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