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
UsernamePublicRestriction

Settling In To The “New Normal”: Midway Through 2012, Another Banner Year For Drug Approvals Is Within Reach

This article was originally published in Pharmaceutical Approvals Monthly

Executive Summary

The forecast for 2012 approvals looks sunny. FDA approved almost as many novel drugs in the first half of 2012 as it did in the first half of its record-breaking 2011 – and the agency has more than twice as many pending NME applications with user fee goals in the next six months as it had last year.

You may also be interested in...



Encore? FDA Could Come Close To Record 2012 NME Count This Year

With 19 novel agents approved so far in 2013 and a full slate of candidates under review, the recovery in novel agent approvals after the doldrums of the 2000s is likely to continue even if the agency falls short of last year’s 45 approvals. Watch for action on the first “breakthrough” therapies submitted and advances in hepatitis C treatment.

Encore? FDA Could Come Close To Record 2012 NME Count This Year

With 19 novel agents approved so far in 2013 and a full slate of candidates under review, the recovery in novel agent approvals after the doldrums of the 2000s is likely to continue even if the agency falls short of last year’s 45 approvals. Watch for action on the first “breakthrough” therapies submitted and advances in hepatitis C treatment.

FDA Sees Another Submission Decrease In FY 2011, Increases Application Fees

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

Related Content

Topics

Related Companies

UsernamePublicRestriction

Register

PS005133

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