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

New Approach Would Overcome Legacy Burden Of ‘Electronic Paper’

Executive Summary

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.

You may also be interested in...



US FDA Drops Plan To Simplify Pharmaceutical Plant Reporting

Industry complained draft guidance would have made manufacturing establishment information harder to report, not easier.

The Post-Shutdown Quality Lowdown

Quality oversight activity began ramping back up after the partial US government shutdown, even as EU oversight activities entered into a Brexit-related slowdown.

FDA Seeks Further Dialogue On Effort To Standardize CMC Application Data Elements

FDA wants feedback on a proposal to standardize the data elements of the quality and chemistry, manufacturing and controls portions of applications. The agency says such a plan will enable consistency in the content and format of CMC data submitted, thus providing a consistent look and feel for every application.

Topics

Related Companies

UsernamePublicRestriction

Register

PS142283

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