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

Unapproved Zika Tests Attract FDA 'Untitled' Letters

This article was originally published in The Gray Sheet

Executive Summary

Two companies and two hospitals are marketing Zika virus diagnostics without FDA go-ahead, the agency said in letters that asked the organizations for data supporting their assays.

You may also be interested in...



Can Novo’s Oral Semaglutide Shake Up Indian Diabetes Segment?

Novo Nordisk's oral semaglutide debuts in India at a monthly cost of about $135 and promises to transform diabetes management in the country. Will it impact the SGLT-2 inhibitor class and potentially cannibalize injectable GLP-1 receptor agonists?

The Quality Lowdown: More Inspection Delays, More Findings On Sterility And Investigations

US FDA hits firms in New Jersey, South Korea and China with warning letters. Meanwhile, Catalent and several outsourcing facilities work on Form 483 inspection findings as Mylan, Viona and Lohxa announce drug recalls.

US FDA’s New Drug Median Review Time Held Steady At Eight Months In 2021

The median review time for novel agents at CDER hasn’t changed in five years. Our infographic offers a look at the tortoises and hares (all of them winners because they got approved).

Topics

Related Companies

UsernamePublicRestriction

Register

MT034617

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