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

UsernamePublicRestriction
UsernamePublicRestriction

ANDA Stress Test: End-Of-Year Submission Bolus Pressures US FDA Review System

Executive Summary

As more generic applications arrive, Office of Generic Drugs staff may have a tougher time reaching review goals.

Advertisement

Related Content

US FDA Might Be Temporarily Headed By Ostroff As Califf Sets His Departure
Generic Application Quality Showing Signs Of Improvement
ANDA Submission Wave Continues; Is A Crest Near?
FDA Aims To 'Pierce The Rhetoric' On Generic Application Backlog
Complex ANDAs To Be Allowed Pre-Submission Product Meetings
ANDAs Can Get Priority, Eight-Month Reviews Under User Fee Deal
Dark, Then Dawn: ANDA Workload Approaching Steady State After 2014 Eruption
Generic Reviews Steaming Ahead, But Are Storm Clouds On The Horizon?
ANDA Avalanche: How Will FDA Deal With The 600 Received This Month?
GDUFA Performance Goals For Fiscal Years 2013-2017

Topics

Advertisement
UsernamePublicRestriction

Register

PS119790

Ask The Analyst

Please Note: You can also Click below Link for Ask the Analyst
Ask The Analyst

All set! This Question has been sent to 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