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 Testing Data Exchange Standards For Drug Specifications Under PQ/CMC Pilot

Executive Summary

FDA announces the rollout of a pilot program with industry to exchange data on quality specifications for the Common Technical Document’s Module 3. The agency plans to exchange data on other portions of the CTD’s quality section later this year. The data exchange would largely replace the “hunting and pecking” for information in PDFs that reviewers have to do to locate quality information in NDAs and ANDAs.

You may also be interested in...



Woodcock: The US FDA Sets The Stage For Global Quality Dossiers

New approach could eliminate minor differences among authorities, enabling pharmaceutical manufacturing processes to become truly global.

How FDA Says Its KASA Plan Will Streamline Quality Reviews

FDA officials described some of the work being done to advance its KASA initiative, under development to make it easier for reviewers to evaluate, and for applicants to submit, quality information in applications. They compared KASA, with its pre-populated data and drop-down menus, to tax return software.

 

FDA Looks To Strengthen, Speed Drug Reviews With Flow Of Quality Data

Lift the burden of paper on drug quality reviews and the pace of innovation is no longer a problem for structural engineers or couriers – or even print or electronic document rooms. The focus at the US FDA is now on enabling direct transmission and analysis of critical quality data.

Related Content

Topics

UsernamePublicRestriction

Register

PS125115

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