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

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

Executive Summary

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.

You may also be interested in...



ANDA Sponsors Urged To Ask DMF Holders About 'Hidden Facilities'

FDA says 16% of ANDAs have an issue with "hidden facilities" that are listed in drug master files but not the ANDAs they are linked with; industry official offers some tips to bridge this communications gap with DMF holders.

US FDA Details Facilities That NDAs, ANDAs Should Note

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.

FDA Warns Against Using Compounded Remdesivir Due To Quality Concerns

Although compounding of certain shortage drugs is allowed during the public health emergency, remdesivir is off limits due to its complexity. Providers should only use the FDA-approved version of the drug, Gilead’s Veklury, the agency says.

Topics

UsernamePublicRestriction

Register

LL111799

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