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

Rates Up, Guidance Absent: FSMA Re-inspection User Fees On Hold

This article was originally published in The Tan Sheet

Executive Summary

Without a guidance for requesting fee reductions, FDA will not bill firms for re-inspections of facilities found non-compliant with manufacturing regulations or for costs linked to a firm failing to comply with a recall order.

You may also be interested in...



FSMA Re-inspection Fees MIA As Waiver Guidance Remains AWOL

FDA will bill supplement and conventional food product firms $248 per hour for re-inspections in the US and $285 per hour outside the country in fiscal 2018, but as it has since Congress passed FSMA, the agency will not collect re-inspection and mandatory recall fees.

OTC Monograph User Fees Up To $34M Floated In Senate Discussion Draft

Bulk of user fees would be raised through facility fees, under Sens. Isakson and Casey’s discussion draft, but there's little time to add the changes to FDA user fee reauthorization bills already moving in Congress.

Supplement Industry Oversight Among FDA Programs Targeted For $86M Budget Cut

The first budget proposal by President Trump suggests research by FDA's National Center for Toxicological Research on food- and nutritional supplement-related issues will be curtailed as part of a $3m cut to the center's appropriation.

Related Content

Topics

UsernamePublicRestriction

Register

OM007836

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