Medtech Insight is part of Pharma Intelligence UK Limited

This site is operated by Pharma Intelligence UK Limited, a company registered in England and Wales with company number 13787459 whose registered office is 5 Howick Place, London SW1P 1WG. The Pharma Intelligence group is owned by Caerus Topco S.à r.l. and all copyright resides with the group.

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

Workshop To Address NGS Draft Guidances

Executive Summary

US FDA is holding a workshop at NIH headquarters on Sept. 23 to get public feedback on two important draft guidances that provide sponsors with more clarity on the agency's thinking on next-generation sequencing tests.

You may also be interested in...



US FDA Gives More Time For Public Response To NGS Microbial Identification Guidance

To give stakeholders more time to respond, FDA has extended its comment period on a draft guidance that addresses next-generation sequencing tests that are used to detect microbes and antimicrobial resistance.

FDA Maps Out Novel Path For NGS Market Access

FDA Commissioner Robert Califf says the agency has worked with NIH and other experts as part of President Obama's Precision Medicine Initiative to map out a new regulatory framework for next-generation sequencing. He said two new draft guidances are meant to help get such tests to market sooner without requiring developers to validate individual genetic variations.

Precision Medicine Plan 'Golden Opportunity' For Device, Diagnostic Firms

A new proposed framework to realize President Obama's Precision Medicine Initiative has significant potential for device and diagnostic companies, according to NIH Director Francis Collins. He says it will give them a "competitive opportunity" to develop cheaper whole genome sequencing tests and open the door to other exciting technologies.

Topics

Latest Headlines
See All
UsernamePublicRestriction

Register

MT103740

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