In Vivo 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

IVDs For Presence of Biothreats Should Evaluate Animal Specimens - FDA

This article was originally published in The Gray Sheet

Executive Summary

Developers of in vitro diagnostic tests for identification of biothreat agents should evaluate animal specimens and spiked plasma when seeking FDA approval, according to FDA's Microbiology Devices Panel.

You may also be interested in...



ANALYTE SPECIFIC REAGENT LABELING CHANGES DUE BY NOV. 1998 UNDER FDA FINAL RULE; ASR MANUFACTURERS TO BE RESPONSIBLE FOR PREMARKET FILINGS, FDAers SAY

Analyte specific reagent manufacturers have until Nov. 23, 1998 to meet labeling and other requirements of the ASR final rule published by FDA Nov. 21. The one-year phase-in gives firms the opportunity to "deplete their current stock of labels," the agency explains.

Big Data Offers International Benefits

The HMA-EMA Big Data Task Force has offered recommendations to use data for the benefit of public health.

Spin-Out A Neat Solution For Sanofi’s Manufacturing Millstone

UsernamePublicRestriction

Register

MT013694

Ask The Analyst

Ask the Analyst is free for subscribers.  Submit your question and one of our analysts will be in touch.

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