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

ANDA Sponsors May Receive Early Notification Of Upcoming Actions, Woodcock Says

This article was originally published in The Pink Sheet Daily

Executive Summary

Concept would allow more time for sponsors to make launch plans and could help improve communication under GDUFA.

You may also be interested in...



Generic Drug Sponsors Seek Advance Notice Of Approvals From US FDA

Pre-launch communication from agency would allow sponsors to ramp up commercial activities and could head off some innovator company legal challenges to ANDA approvals, attorneys say; CDER’s Moscicki suggests GDUFA goal dates now provide sponsors some level of predictability.

Generic Drug Sponsors Seek Advance Notice Of Approvals From US FDA

Pre-launch communication from agency would allow sponsors to ramp up commercial activities and could head off some innovator company legal challenges to ANDA approvals, attorneys say; CDER’s Moscicki suggests GDUFA goal dates now provide sponsors some level of predictability.

Late-Cycle Approval Predictions Not A Good Idea, FDA Says

OND Director John Jenkins says the late-cycle meeting in the new PDUFA review model will offer a lot of information to sponsors, but likely will not be predictive of application approvability.

Related Content

Topics

Latest Headlines
See All
UsernamePublicRestriction

Register

PS075048

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