Pink Sheet is part of Pharma Intelligence UK Limited

This site is operated by Pharma Intelligence UK Limited, a company registered in England and Wales with company number 13787459 whose registered office is 5 Howick Place, London SW1P 1WG. The Pharma Intelligence group is owned by Caerus Topco S.à r.l. and all copyright resides with the group.

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

GDUFA Self-Identification Woes Can’t Deflate Industry, FDA Enthusiasm

This article was originally published in The Gold Sheet

Executive Summary

As the grace period nears its close, industry officials say they expected problems getting generic drug manufacturing facilities to self-identify under the new user fee requirement; meanwhile, FDA expects to hire nearly three times the staff in the Office of Generic Drugs to meet GDUFA commitments.

You may also be interested in...



GDUFA Facility Self-Identification Pace Slow As Deadline Neared

API, finished dosage form and other facilities in the generic drug supply chain must submit information to FDA by Dec. 3. As of Nov. 18, about one-third had complied, potentially affecting user fee amounts.

Backlog Backfire: FDA Sees Increase In Pending Generic Applications At Deadline

The agency was expecting many pending generic drug submissions to be withdrawn because sponsors would not want to pay the one-time backlog fee, but instead saw a substantial increase near the end of FY 2012.

Generic Drugs Gain Status Boost Within CDER

More than just a bureaucratic shell game, the promotion of the Office of Generic Drugs to “super office” status signals CDER Director Janet Woodcock’s tightened focus on generic drugs.

Related Content

Related Companies

Latest News
See All
UsernamePublicRestriction

Register

PS000659

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