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

Epitope

This article was originally published in The Gray Sheet

Executive Summary

Files additional materials with FDA in support of the company's premarket approval application for OraSure, an oral specimen collection device for use in detection of antibodies for HIV-1. The filing, which the firm submitted in response to concerns raised at a Dec. 18 FDA blood products advisory committee meeting ("The Gray Sheet" Dec. 21, 1992, p. 5) and subsequent sessions with FDA staff, "covers proposed labeling, a mechanism for confirmation of positive screening tests, procedures for subject counseling, and training of specimen collection personnel," according to Adolph Ferro, Epitope president and chief executive officer.
UsernamePublicRestriction

Register

MT000360

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