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

What Not To Do When An FDA Inspector Comes Knocking At Your Door

This article was originally published in The Pink Sheet Daily

Executive Summary

FDA tweaks final guidance on what constitutes interference with FDA inspections to include examples of ‘reasonable’ explanations for sponsor delays; industry had requested many other changes.

You may also be interested in...



US FDA Invites Warning Letter Follow-Up Inspection Alternative Proposals As Pandemic Persists

With inspectorate grounded by COVID-19, agency cannot clear remediated facilities or approve related applications – unless industry has a better idea.

US FDA Guidance On Interference With Inspections Needs More Detail, Attorneys Say

Agency should clarify how quickly it expects requested documents to be produced before a company is determined to have delayed an inspection, attorneys say during a FDLI meeting discussion of how a 2012 law enabling the agency to put a foreign facility on import alert for delaying, limiting, or refusing an inspection has played out.

In Brief: FDA testing, FDA inspection creep, Q11 ‘clarified,’ enforcement dashboard, data integrity, more

FDA posts testing results; regulatory creep knocks at door; ICH Q11 ‘clarified’ for Europe; FDA’s new enforcement dashboard; data integrity insights; FDA’s Arista challenges India; FDA’s new quality platform.

Related Content

Topics

Related Companies

UsernamePublicRestriction

Register

OM003387

Ask The Analyst

Please Note: You can also Click below Link for Ask the Analyst
Ask The Analyst

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