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
UsernamePublicRestriction

GHTF Issues Guidance, Launches Pilot Program On Adverse Event Reporting

This article was originally published in The Gray Sheet

Executive Summary

An "Adverse Event Reporting Guidance" recently released by the Global Harmonization Task Force Study Group 2 could influence FDA to drop its requirement that manufacturers report adverse events even when they are foreseeable and appear in device labeling warnings.

You may also be interested in...



Polish Industry Fighting Against Advertising Tax On Supplements

Advertising dietary supplements in Poland will incur a new tax under proposals from the country's Ministry of Health. While the government claims the motivation is to promote healthy eating choices, industry says supplements have been unfairly linked to poor dietary choices without evidence.

England’s NICE Future Proofs Approach To Using Data

UK HTA body NICE is looking to the future and rethinking its approach to data and how they inform its guidance.

Krka Responds To Romanian Allegations

Slovenia’s Krka has responded to media reports of “irregularities” at its Romanian subsidiary – including allegations of bribing local doctors to prescribe its products – by pledging to form a special investigation team to immediately examine the matter.

UsernamePublicRestriction

Register

MT011498

Ask The Analyst

Please Note: You can also Click below Link for Ask the Analyst
Ask The Analyst

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