Pink Sheet is part of the Business Intelligence Division 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

Cleaning Up The ‘Orange Book’: US FDA Clarifies Market Status Reporting Requirements

Executive Summary

Draft guidance addresses sponsors’ obligations to notify agency about drugs withdrawn from sale or not available for sale within 180 days of approval; FDA has reviewed ‘substantial portion’ of more than 10,000 one-time marketing reports that were due in February 2018.

Advertisement

Related Content

Outlook For Orange Book Update Not Too Rosy
Drug Sponsors Who Fail To Submit One-Time Marketing Report Face Big Penalty
FDA Aims To 'Pierce The Rhetoric' On Generic Application Backlog

Topics

Advertisement
UsernamePublicRestriction

Register

PS124681

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