Pink Sheet is part of the Business Intelligence Division 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

Combination Products Offer Regulatory Option For Novel Switches

This article was originally published in The Tan Sheet

Executive Summary

A novel switch application comprising a drug and a device would be “a classic combination product” and FDA has a framework for evaluation, says Bradley Merrill Thompson, an attorney who focuses on medical device law.

Advertisement

Related Content

Califf Supports Changing Combo Product Pathway; FDA Developing Proposal
Califf Supports Changing Combo Product Pathway; FDA Developing Proposal
FDA Taking Steps To Simplify Combo Product Consultations
FDA Taking Steps To Simplify Combo Product Consultations
Combo Products Guidance Could Help Point Novel OTC Switches In Right Direction
Combo Products Guidance Could Help Point Novel OTC Switches In Right Direction
FDA Sketched NSURE Novel Switch Initiative In 2012
FDA Sketched NSURE Novel Switch Initiative In 2012
FDA Sketches NSURE Novel Switch Initiative In 2012
FDA To Tackle Critical Generics Issue In Switch Paradigm Debate

Topics

Advertisement
UsernamePublicRestriction

Register

PS105699

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