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 Sponsors Get Some Relief on New Stability Requirements

This article was originally published in The Gold Sheet

Executive Summary

FDA still expects rush of ANDA submissions before new stability requirements take effect June 20, but agency has eliminated some tests and reduced some batch sizes in response to industry comments.

You may also be interested in...



ANDAs To Include Six Months Of Stability Test Data Under FDA Draft Guidance

The agency advises sponsors to follow the stability testing recommendations in the International Conference on Harmonization guidances; three companies submit comments seeking clarification from FDA.

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The agency was expecting many pending generic drug submissions to be withdrawn because sponsors would not want to pay the one-time backlog fee, but instead saw a substantial increase near the end of FY 2012.

US FDA Facility Compliance Actions Could Speed Up Despite Inspections Freeze

With inspectors no longer out in the field, they have more time to wrap up work on previously completed facility evaluations, attorney Howard Sklamberg says; inspections freeze could delay manufacturers’ abilities to bring facilities into compliance following adverse inspection findings, as well as agency reclassifications of facility status.

UsernamePublicRestriction

Register

PS000841

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