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

Aggregating Adverse Events Data Should Be Sponsor Responsibility: FDA

Executive Summary

The US agency has published a draft guidance outlining investigator and sponsor responsibilities in which it says sponsors are better suited to report aggregated adverse events to regulators.

You may also be interested in...



US FDA Proposes Making It Easier To Get Certain HIV Tests To Market

Regulators say that despite millions of HIV viral load monitoring tests on the market over the past 25 years, there has only been on class II recall for the products, which warrants easing their path to market.

Podcast: How Do You Protect Yourself When Your AI Makes Mistakes?

Medtech Insight spoke with Sidley Austin attorneys about the future of medical device AI negligence litigation and what manufacturers can do to protect themselves.

AI Expert: Awareness Is Key To Managing Biases

A Walden University professor discussed various types of biases AI/ML developers need to take into consideration during the recent Xavier Health AI Summit. She noted a working group will produce a white paper laying out different types of biases to raise awareness.

Topics

UsernamePublicRestriction

Register

MT144518

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