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

CBER "COMPLETE REVIEW" LETTERS COULD REPLACE "APPROVABLE/NOT APPROVABLE"; INDUSTRY, FDA LIKELY TO ADDRESS "APPROVABLE" DECISIONS IN PDUFA REAUTHORIZATION

Executive Summary

FDA's Center for Biologics Evaluation & Research is using "complete review" letters to replace "approvable" or "not approvable" letters for non-user fee applications.

You may also be interested in...



“Complete Response” Reg Proposes Deficiency Letter For Withdrawn NDAs

The definition of an efficacy supplement, which covers Rx-to-OTC switch applications, would be written into regulation for the first time under a new proposed rule issued by FDA

Part D Discount Liability Coming Into Focus: CMS Releases Drug Cost Data

Newly released Medicare Part D data sheds light on the sales hit that branded pharmaceutical manufacturers will face when the coverage gap discount program gets under way in 2011

FDA Skin Infections Guidance Spurs Debate On Endpoint Relevance

FDA appears headed for a showdown with clinicians and the pharmaceutical industry over the proposed new clinical trial endpoints for acute bacterial skin and skin structure infections, the guidance's approach for justifying a non-inferiority margin and proposed changes in the types of patients that should be enrolled in trials

UsernamePublicRestriction

Register

ID005817

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