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

GMP Dispute Resolution Pilot May Build In Delay Before Form 483 Is Issued

Executive Summary

FDA's GMP dispute resolution pilot could allow drug inspectors a "short post-inspection delay" prior to issuing a Form 483 manufacturing report

You may also be interested in...



FDA GMP Dispute Resolution Guidance Allows 10 Days To Raise Objections

FDA's dispute resolution draft guidance will allow manufacturers 10 days to challenge FDA inspection findings

FDA GMP Dispute Resolution Guidance Allows 10 Days To Raise Objections

FDA's dispute resolution draft guidance will allow manufacturers 10 days to challenge FDA inspection findings

GMP Dispute Resolution Draft Guidance To Issue In Next Few Months

FDA expects to issue a draft guidance in the coming months on a formal dispute resolution process for scientific and technical issues that arise during inspections

Related Content

UsernamePublicRestriction

Register

GB140150

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