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

GDUFA III: Convening Enhanced Mid-Cycle Meeting Will Cost Sponsors

Executive Summary

Requesting the new meeting type for an ANDA assessment will trigger a goal date extension with another possible should an unsolicited application amendment also be necessary.

You may also be interested in...



US FDA’s New Acting Generics Chief Relearning System After 24 Years Of Experience

Acting OGD Director Susan Rosencrance says in an interview that the generics assessment system has evolved substantially since she moved to the Office of Pharmaceutical Quality in 2015.

FDA’s ‘Imminent Action’ Policy Likely Not Best Path For ANDAs To Address Late Brand Label Changes

The policy allowing the FDA to work past a goal date could be used to deal with the generic delaying tactic, but an industry expert said other avenues to quickly dispatch labeling issues may be more appropriate.

FDA’s ‘Imminent Action’ Policy Likely Not Best Path For ANDAs To Address Late Brand Label Changes

The policy allowing the FDA to work past a goal date could be used to deal with the generic delaying tactic, but an industry expert said other avenues to quickly dispatch labeling issues may be more appropriate.

Related Content

Topics

Latest News
See All
UsernamePublicRestriction

Register

PS145174

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