IPQ Inside the global regulatory dialogue

Changes to OGD’s API DMF Process Target Submission Quality and Review Streamlining

Aug 30th, 2012

Please Log in to print the full article

Significant changes are being made by FDA’s Office of Generic Drugs (OGD) to its active ingredient Drug Master File (DMF) review program to improve the quality of industry submissions and streamline the review process so...

You must be a paid subscriber to continue reading this article. If you are a paid subscriber, please Log in. If you are not a paid subscriber, please subscribe now.

©2021 IPQ Publications