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

Safety Reporting For Combo Products To Be Clarified In FDA Proposed Rule

Executive Summary

A proposed rule wending its way through regulatory review at FDA would clarify post-market safety reporting requirements for combination products

You may also be interested in...



Combo Products Primary Mode Of Action Rule Takes Effect In November

FDA is revisiting its Intercenter Agreements on combination product jurisdictions in light of its final rule defining primary mode of action

Solvay's Androgel REMS Proposal May Need More Restrictions - Cmte.

Solvay may need a more restrictive Risk Evaluation and Mitigation Strategy for AndroGel 1% to adequately warn against the danger of secondary transfer of the testosterone gel, according to some members of FDA's Pediatric Advisory Committee

FDA Complete Response Slows Down, But Won't Stop, Lundbeck's Serdolect

Agency comes to same conclusion as advisory committee: the risky schizophrenia drug could get approved if an appropriate patient group is identified.

UsernamePublicRestriction

Register

ID1132679

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