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

ANDA Sponsors Could Lose Exclusivity Because COVID-19 Prevented An Inspection … Or Not

Executive Summary

US FDA will determine on a case-by-case basis whether its inability to inspect a facility because of the pandemic could result in 180-day exclusivity forfeiture for first generic filers.

You may also be interested in...



FDA CDER Compliance Office Answered Pandemic With Fewer Inspections, Greater Discretion

Fewer inspections but more warning letters, import alerts and drug-shortage discretions were seen as office sought to ameliorate COVID-19 impacts.

US FDA Explores Pandemic Inspection Alternatives, Post-Pandemic Strategies

Agency's Janet Woodcock  and Judy McMeekin say the FDA is looking at options like livestream plant videos while preparing to address backlog after inspections can resume.

Drug Manufacturers Beg US FDA To Inspect Facilities, But Still Find Difficulties

As agency implements testing program for its staff, sponsors are drawing up protocols to ensure inspector safety and forwarding them to FDA, but still can’t trigger an inspection.

Related Content

Topics

UsernamePublicRestriction

Register

PS144108

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