Pink Sheet 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 consults on co-development of unmarketed drugs for use in combination

This article was originally published in SRA

Executive Summary

The US Food and Drug Administration has issued for consultation draft guidance to help pharmaceutical companies in the co-development of two or more previously unmarketed drugs to be used in combination to treat a disease or a condition1-3.

You may also be interested in...



Global Medtech Guidance Tracker: March 2020

Stay current on regulatory guidelines from around the world with Medtech Insight's Guidance Tracker. Sixty-nine guidance documents have been posted on the tracker since its last update.

UK MHRA Finds Labs Releasing Unreliable Data Due To Pressure From Pharma

A UK regulator with the MHRA is concerned that bioanalytical laboratories are not being given enough time to do their job properly by drug companies under pressure to ensure their clinical trials remain on schedule. 

UK MHRA To Medtech: Check Before Applying For Non-COVID-19 Trials

The UK regulator is expecting a rise in amendments and deviations to ongoing clinical investigations of medical devices due to the COVID-19 pandemic and has issued advice on how companies should manage these. 

UsernamePublicRestriction

Register

PS115879

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