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

FDA Guidance Sheds Light On Human Factor Studies For Combo Products

This article was originally published in The Gray Sheet

Executive Summary

Questions from companies and FDA reviewers about human factor design and data requirements for combination products continue to grow. In response, the agency has issued a draft guidance.

You may also be interested in...



Companies Want New US FDA Council To Help Resolve Inter-Agency Combo Product Disputes

A range of topics were raised in feedback provided by industry groups to FDA about what the priorities should be for the agency's new Combination Products Policy Council, but addressing inter-center disagreements was a repeat concern. Also raised: misaligned communication policies; pediatric combo-product reviews; and implementation of the 21st Century Cures Act.

ANDAs For Drug/Device Combos Face High Bar At US FDA; Epipen, Advair May Benefit

Generics must be able to be administered without provider intervention or patient retraining, draft guidance says.

ANDAs For Drug/Device Combos Face High Bar At US FDA; Epipen, Advair May Benefit

Generics must be able to be administered without provider intervention or patient retraining, draft guidance says.

Related Content

Topics

UsernamePublicRestriction

Register

MT034933

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