Pink Sheet 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


FDA Combo Product Final Rule Adds "Intended" Use To Primary Mode Of Action Definition

This article was originally published in The Pink Sheet Daily

Executive Summary

Final rule includes an algorithm for the Office of Combination Products to use if primary mode of action cannot be established.

You may also be interested in...

Combo Product Industry Coalition Proposal Elevates Post-Approval Issues

Genzyme, Roche, Guidant are among the firms represented by the Combination Product Coalition to focus on improving post-approval regulatory pathways, such as modifications and cross-labeling for “virtual” combo products.

“Primary Mode Of Action” Reg To Facilitate Review Center Assignment Of Combo Products

FDA’s proposed rule defines primary mode as “the single mode of action of a combination product that provides the most important therapeutic action of the combination product.”

FDA Eyes Upclassification, Labeling Guidance To Address Stapler Risks

The US agency sent a letter to health-care providers spotlighting its analysis of the increasing numbers of adverse events linked to surgical staplers and implantable staples, and its plans for a draft guidance on labeling and an advisory panel meeting to consider a 510(k) requirement for the products.





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