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

FDA’s Good Review Management Practices To Debut In “Near Future”

This article was originally published in The Pink Sheet Daily

Executive Summary

Even as the agency wrestles with the transformation brought by FDAAA, shifts in how it processes NDAs may be the "most important," CDER official says.

You may also be interested in...



FDA Says New GRMPs Will Shift Drug Review Workload To Earlier In Cycle

Sponsors and FDA reviewers will have to adjust to the workload of a drug review shifting earlier in the review cycle as the agency implements Good Review Management Principles, now renamed the "21 Century Review Process.

FDA Says New GRMPs Will Shift Drug Review Workload To Earlier In Cycle

Sponsors and FDA reviewers will have to adjust to the workload of a drug review shifting earlier in the review cycle as the agency implements Good Review Management Principles, now renamed the "21 Century Review Process.

Good Review Principles Implementation Could Threaten Six-Month Priority Review Timeframe

OND Director Jenkins tells FDC/Windhover conference that newly-defined best practices are difficult to accomplish within six months and "nearly impossible" if the priority application must face an advisory panel.

Related Content

Topics

Latest News
See All
UsernamePublicRestriction

Register

PS068350

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