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


FDA Questions First-To-File Exclusivity As Generic Reforms Pass Senate

This article was originally published in The Tan Sheet

Executive Summary

FDA has reservations about the current first-to-file basis for 180-day exclusivity, FDA Chief Counsel Daniel Troy acknowledged at a June 17 Senate Judiciary Committee hearing on generic drug reforms

You may also be interested in...

FDA Generic Final Rule Requires Polymorph Test Data For Patent Listing

FDA's final rule to reform Hatch/Waxman requires an innovator company to test data to establish that a polymorph claimed in a patent is the same as the active ingredient in the NDA

Generic Drug Reforms: FTC Notification Bill Appears Ready To Move In 2003

A bill to require reporting of brand/generic patent settlements to the Federal Trade Commission appears ready to move early in the 108th Congress

FTC Backs Single 30-Month Stay On Generic Approvals In Patent Litigation

The Federal Trade Commission supports a limit of one 30-month stay of approval on generic drugs in patent litigation





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