Pink Sheet is part of Pharma Intelligence UK Limited

This site is operated by Pharma Intelligence UK Limited, a company registered in England and Wales with company number 13787459 whose registered office is 5 Howick Place, London SW1P 1WG. The Pharma Intelligence group is owned by Caerus Topco S.à r.l. and all copyright resides with the group.

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

Combination Products: US FDA Aims For Limited Two-Application Solutions

Executive Summary

In announcing guidance stating one application generally is sufficient for a combination product, FDA asks for comments on situations where two would be needed.

You may also be interested in...



FDA's Drug Center Permits Some Combo Product Software To Be Submitted As DMFs

New draft guidance from the US agency allows electronics or software that will be used across multiple combination products to be submitted as a Type V drug master file (DMF), potentially streamlining the assessment process.

CDER Permits Some Combo Product Software To Be Submitted As DMFs

New draft guidance allows electronics or software that will be used across multiple combination products to be submitted as a Type V drug master file, potentially streamlining the assessment process.

US FDA's Integrated Review Doc: Industry Says Don't Lose The Detail

Stakeholders, some worried about "groupthink," tell the US FDA they want the individual discipline comments on newly approved drugs to stay in action packages because of the valuable insights they provide.

Related Content

Topics

Related Companies

Latest Headlines
See All
UsernamePublicRestriction

Register

PS124706

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

Cancel