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

FDA Web Portal Eases Pre-ANDA Meeting Request Process

Executive Summary

New CDER Direct NextGen Collaboration Portal allows sponsors of complex ANDAs to submit and track formal meeting requests.

You may also be interested in...



FDA Approving Complex Generics Pre-ANDA Meeting Requests At Higher Rates

Approval rates for complex-drug pre-ANDA meeting requests are climbing. FDA’s hope is that the meetings will hasten approvals of these hard-to-manufacture generics, which could put a dent in US healthcare costs.

ANDA Sponsors Need To 'Slow Down' And Focus On Quality, US FDA Generics Director Says

Kathleen Uhl says applicants can avoid RTRs by conducting quality checks before submission, but sponsors may have difficulty changing their approach because of how fundamental application speed is to their business model.

ANDA Sponsors Need To 'Slow Down' And Focus On Quality, US FDA Generics Director Says

Kathleen Uhl says applicants can avoid RTRs by conducting quality checks before submission, but sponsors may have difficulty changing their approach because of how fundamental application speed is to their business model.

Related Content

Topics

Related Companies

UsernamePublicRestriction

Register

PS121719

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