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

ANDA Deficiencies Persist Despite QbR; Reviews to Focus More on Excipients

This article was originally published in The Gold Sheet

Executive Summary

Despite full adoption of question-based review in the generic drug industry, some of the chemistry and bioequivalence issues QbR was meant to help resolve have persisted, say officials from FDA’s Office of Generic Drugs.

You may also be interested in...



FDA Developing Initiatives to Improve Quality of Drug Master Files

The quality of DMFs is expected to improve thanks to a soon to be released question- based review system for DMF holders as well a recently issued draft guidance calling for new procedures for reviewing master files called “completeness assessments,” said a pharmaceutical industry official who was a former team leader in FDA’s Office of Generic Drugs.

GDUFA Timetable Unclear, But Negotiations Will Begin With Lots Of Agreement - Except For Mylan

Coalition and GPhA expect to be on the same page at FDA public meeting, but Mylan proposes alternative user fee structure based on establishment fees.

FDA Officials Urge Generic Drug Industry to Adopt QbD to Improve Submissions

First to file, worst to file? FDA looks to turn the tables on the generics submissions race and award first-to-file status to ANDA applicants who invest in quality by design. Agency urges generics firms to adopt QbD approach by 2011. The problem is many non-QbD first-to-file ANDAs languish in review while firms learn how to make the products, wasting industry and FDA resources - especially with complex modified-release products. Once in production, recalls and warning letters could follow while firms continue learning the hard way.

Related Content

UsernamePublicRestriction

Register

OM005224

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