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 Sees Another Submission Decrease In FY 2011, Increases Application Fees

Executive Summary

The figures continue a recent trend of decreases in fee-paying full application equivalents but were not as low as had been estimated.

You may also be interested in...



PDUFA, Biosimilar Application Fees To Rise 10.7%; FDA’s Workload Adjuster Needs Work

Facility and product user fees will increase by more than 5% for fiscal year 2014; FDA calculated the fees using a revised workload adjuster because the previous method failed to reflect increasing complexity of the drug review process.

FDA Drug Review Costs Rise, But Personnel Spending Flattens

Less than 60% of the total spending on reviews was attributed to employee compensation and benefits in FY 2011. FDA says it is normal, but the figure is lower than costs seen in recent years.

FDA Spending Less Time On INDs, More On NDAs and BLAs

Five-year averages used in calculations of FY 2013 user fee rates show a decrease in time devoted to INDs and an increase in time spent on NDAs and BLAs. The average submission volume in both categories still increased.

Related Content

Topics

UsernamePublicRestriction

Register

PS054645

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