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

US FDA Details Facilities That NDAs, ANDAs Should Note

Executive Summary

The US FDA has made a renewed effort to clarify the types of manufacturing facilities that need to be listed on the Form FDA 356h and Module 3 of the CTD in submissions. Often reviewers find this information missing, whicn can result in a refuse to file action.

You may also be interested in...



The FDA's Best Tips For Avoiding Drug Master File Setbacks

Impurity assessment and starting materials justification are the top reasons for deficiencies related to Type II drug master files in first-cycle DMF reviews while the US FDA continues to see "hidden facilities" that are listed in DMFs but not the ANDAs they are linked with.

US FDA Drops Plan To Simplify Pharmaceutical Plant Reporting

Industry complained draft guidance would have made manufacturing establishment information harder to report, not easier.

No More 'Hidden' Facilities, US FDA Tells Generic Sponsors

Agency officials don't care if DMF holder doesn't give access to its entire facility list; FDA says industry is responsible for listing all facilities that could be used as part of ANDA.

Related Content

Topics

UsernamePublicRestriction

Register

OM013658

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