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


QUOTED. Jan. 22, 2019. Susan Neadle.

Executive Summary

Combination products add complexities to many parts of the regulatory process, and that includes US FDA facitilty inspections. J&J's Susan Neadle highlights here the importance of speaking the language of both drug and device regulations when an investigator shows up at your combo product facility.

"If the investigator is asking questions, and there is an area where there are interactions between the drug and device worlds, you want to make sure that the person who’s doing the talking – along with anyone who might be transcribing – understands the language of devices and drugs." – Susan Neadle, senior director for Global Value Chain Quality Design, Johnson & Johnson  

Click here for a free trial of Medtech Insight

Related Content





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