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

US FDA Hoping To Spur More ANDA Pre-Submission Meetings During GDUFA III

Executive Summary

The FDA believes conducting a pre-submission meeting when a complex generic application has unusual elements can increase the likelihood of a first-cycle approval.

You may also be interested in...



Holding ANDA Labeling Review Until Late Cycle Could Minimize Delays From Last-Minute Changes

A GDUFA III adjustment could allow more labeling changes during the review cycle and reduce assessment cycles.

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

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.

GDUFA III Agreement Will Constrain Fee Revenue Increases

Generic user fee program's next iteration will also offer improved mid- and post-assessment communications for sponsors to receive feedback from US FDA.

Topics

UsernamePublicRestriction

Register

PS145271

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