Generics Bulletin 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

Will GDUFA III Curtail Priority Assessments?

Executive Summary

US FDA's expedited pathway for generics seems to provide more benefits for amendments than for original ANDAs.

You may also be interested in...



US FDA's Generics Program Reaches 'Steady State' Milestone

OGD Director Uhl says program is now in balance between the number of submissions and agency review actions.

Let's Get Real – ANDA Approval Likely Takes More Than Two Years, US FDA Says

Office of Generic Drugs Director Kathleen Uhl calls a two-cycle approval timeline a realistic expectation for ANDA approval, but would not say that most ANDAs will fall into the paradigm.

Unhappy With GDUFA II? Note It For GDUFA III, FDA Says

US agency says it is implementing generic drug user fee program as outlined in commitment letter and any changes should be discussed at negotiations for the 2022 renewal.

Related Content

Topics

Related Companies

UsernamePublicRestriction

Register

ID014775

Ask The Analyst

Please Note: You can also Click below Link for Ask the Analyst
Ask The Analyst

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