Pink Sheet is part of the Business Intelligence Division 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


ANDA Pre-Submission Meetings A 'Challenge' To Integrate Into Development Timelines

Executive Summary

US FDA officials appears worried about workload created by product development and pre-submission meetings for complex generics.

Related Content

US FDA's Generic Research May Include EpiPen And Competitors
Unhappy With GDUFA II? Note It For GDUFA III, FDA Says
US FDA Commits To Meeting With Complex ANDA Sponsors, Works Hard To Avoid It
FDA Web Portal Eases Pre-ANDA Meeting Request Process
Complex ANDAs: Early Meetings With FDA Can Generate Bonus Communication
Complex ANDAs To Be Allowed Pre-Submission Product Meetings
Biosimilars Will Get PDUFA-Style Reviews Under New User Fee Plan
Sponsors, FDA Reviewers To Get More Flexibility Under New User Fee Program
FDA Met Biosimilar Review Timelines But Missed Meeting Goals In 2015





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