Generics Bulletin 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

US FDA Continues Reviewing Marketing Reports, Will It Punish Scofflaws?

Executive Summary

Six months after submission deadline, about one-third of one-time marketing status reports have been reviewed, agency says.

You may also be interested in...



Inside The ANDA Parking Lot

A firm will take ownership of US ANDAs from manufacturers unwilling to pay program fees or withdraw the approved generic drug application; is it a novel concept allowing future marketing options or simply fee avoidance?

US FDA's Generic Research Projects Appear To Be Opening Way For ANDAs

Pre-ANDA meeting requests were high in some product categories where FDA conducted research projects, suggesting agency may influence sponsors' development priorities.

Outlook For Orange Book Update Not Too Rosy

With about 20,000 products eligible for US marketing status report on drugs in Orange Book, there is no timeline for all changes to be made.

Related Content

Topics

Related Companies

UsernamePublicRestriction

Register

GB002498

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