Generics Bulletin 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


Updated DMF Guidance Reflects GDUFA II

Draft FDA Guidance Also Requires Electronic Submission

Executive Summary

US FDA’s first revision of its foundational Drug Master Files guidance in 30 years contains few surprises but incorporates statutory and regulatory actions. Among the changes: a new section requiring electronic submission of DMFs and a section reflecting GDUFA II completeness assessments in Type II DMFs.

You may also be interested in...

US FDA Will Allow Transitioning Products To Continue Referencing Drug Master Files

The 'technical detail' needed to be resolved in part to ensure there would be no shortages after the 2020 change from regulation as drugs to biologics for certain protein products, the agency said.

FDA Revises Guidance on DMFs and Prior Approval Supplements to Reflect GDUFA II

FDA has revised references in guidance to generic drug user fee requirements that changed under GDUFA II on Oct. 1. One guidance document no longer says for generics firms to pay user fees for prior approval supplement reviews. Another gives review goals for drug master file completeness assessments.

ANDA Sponsors May Need Extra Three Months To Avoid DMF-Related Delays

Under GDUFA, drug master files must pass a completeness assessment before they can be referenced in an ANDA. Sponsors should coordinate better with DMF holders to assure that FDA has adequate review time.


Latest Headlines
See All



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