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

Combination Products Office Finalizing Manufacturing, Adverse Event Rules

This article was originally published in The Gray Sheet

Executive Summary

FDA says final rules on good manufacturing practices and adverse event reporting for combination products could be out as early as this fall.

You may also be interested in...



Device Industry Seeks More Clarity Following Combo Product GMP Final Rule

FDA’s final regulation outlines which manufacturing system requirements apply to products that have drug, device and/or biologic components. The Combination Products Coalition says key details need to be filled in by FDA with guidance.

Industry Seeks More Clarity Following Combo Product GMP Final Rule

FDA’s final regulation outlines which manufacturing system requirements apply to products that have drug, device and/or biologic components. An industry coalition says key details need to be filled in by FDA with guidance.

What's In A Name? FDA Offers More Clarity On The Device-Drug Dividing Line

Recognizing the blurred distinction between some advanced device and drug technologies, FDA has released a pair of draft guidance documents to clarify where certain medical products fall within the agency's regulatory scheme.

Related Content

UsernamePublicRestriction

Register

MT030056

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