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

Fresh From US FDA's Chief Counsel Office, Beth Weinman Talks Qui Tam And Compliance

Executive Summary

Beth Weinman, a former enforcement lawyer in US FDA’s Office of Chief Counsel, recently joined the life sciences and FDA regulatory practice at Ropes & Gray. She spoke with Medtech Insight about whistleblower suits and FDA enforcement priorities.

You may also be interested in...



Top FDA Officials Warn About Non-Vetted Pharmacogenetic Tests After Latest 23andMe Approval

A day after 23andMe gained US FDA go-ahead for a DTC genetic test service to inform patients about their ability to metabolize medications, the agency issued a safety communication, paired with a joint statement from device- and drug-center heads, warning consumers against trusting genetic tests that have not been vetted by FDA.

FDA Clarifies Software Link In Abbott COVID-19 Lab Test Recall

The recall is related to the software’s mixing parameters, which may cause false positives if test samples contaminate each other.

Abbott COVID-19 Lab Test Recall Deemed High-Risk Class I

The recall is related to potential false positives that may occur if a genuine positive test sample overflows into an adjacent sample that would have otherwise tested negative.

Topics

UsernamePublicRestriction

Register

MT124239

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