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

US FDA Preparing For Potential Bolus Of Complex Generic Applications

Executive Summary

Increasing number of product development meetings suggests that many complex generics remain in the development stages.

You may also be interested in...



Teva Identifies ‘Problem Pattern’ Of Complex CRLs Ahead Of GDUFA III

Forecasting up to a dozen complex generic launches by Teva in the US in 2021, executive vice-president for North America commercial Brendan O’Grady said Teva was continuing to push for changes to boost approval rates ahead of GDUFA III next year.

GDUFA III: Some Goals May Be Measured In Business Days Instead Of Calendar Days

ANDA user fee goals likely would have to be reconfigured to account for business days and still maintain the intended length of time.

GDUFA III: Some Goals May Be Measured In Business Days Instead Of Calendar Days

ANDA user fee goals likely would have to be reconfigured to account for business days and still maintain the intended length of time.

Related Content

Topics

Related Companies

UsernamePublicRestriction

Register

GB150935

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