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

Drug Approvals After First-Cycle Review Decline, Parexel Report Finds

Executive Summary

FDA's Center for Drug Evaluation & Research cleared fewer NDAs after one review in 2005 than it did the previous year, according to Parexel International's Bio/Pharmaceutical R&D Statistical Sourcebook 2007/2008

You may also be interested in...



CDER Takes Steps To Meet First-Cycle Review Goals Of GRMP Guidance

ATLANTA - An agency-wide initiative to implement Good Review Management Principles at the Center for Drug Evaluation and Research should lead to more first-cycle reviews, CDER Associate Director of Regulatory Affairs Kim Colangelo said at a June 18 session of the Drug Information Association annual meeting

CDER Takes Steps To Meet First-Cycle Review Goals Of GRMP Guidance

ATLANTA - An agency-wide initiative to implement Good Review Management Principles at the Center for Drug Evaluation and Research should lead to more first-cycle reviews, CDER Associate Director of Regulatory Affairs Kim Colangelo said at a June 18 session of the Drug Information Association annual meeting

First-Cycle Approvals May Rise For Second Consecutive Year – Parexel Report

First-cycle approvals by FDA's Center for Drug Evaluation & Research may continue to rise for a second consecutive year, according to Parexel's Bio/Pharmaceutical R&D Statistical Sourcebook 2006/2007

Related Content

UsernamePublicRestriction

Register

PS048419

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