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

FDA Accelerates Inspection Process With New Concept Of Operations

Executive Summary

'Concept of Operations' document spells out how FDA's realigned inspectorate and program offices will work together to accelerate drug manufacturing facility evaluations and inspections in line with generic and brand drug product reviews. Under the new approach, the agency expects to produce establishment inspection reports, facility classifications and warning letters more quickly, giving applicants more time to avoid manufacturing-related complete response letters.

You may also be interested in...



US FDA Getting Faster At Notifying Drug Facility Owners Of Inspection Status

Agency issued final classification determinations within 90 days after an inspection 86% of the time in fiscal year 2019 and continues to reduce the time interval for sending GMP warning letters, CDER compliance director Donald Ashley tells FDLI conference.

US FDA Could Use More Foreign Investigators If It Could Find Them, Woodcock Says

Hiring travails, inspection pre-announcement, lack of translators highlighted in congressional hearing on FDA foreign inspections.

Early GMP Compliance Seen As A Key To Avoiding Complete Responses

Former FDA compliance official offers advice to biotech startups on how to avoid CMC and GMP complete responses.

Related Content

Topics

UsernamePublicRestriction

Register

PS121399

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