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

Generic drug approvals during GATT transitional period would be allowed by Sen. Pryor's S 1191.

Executive Summary

GENERIC FIRMS COMPLETING "PENULTIMATE STEPS" OF ANDA PROCESS prior to June 8, 1995 would be permitted to market a product during the patent extension resulting from the 20-years-from-filing system adopted in the Uruguay Round Agreements Act under legislation introduced by Sen. Pryor (D-Ark.) Aug. 11. The "Consumer Access to Prescription Drugs Act" (S 1191) defines the "substantial investment" that would allow marketing during the URAA transitional period as: "the development of a product formulation and the manufacture of an experimental batch of a drug that becomes the subject of an application, or the initiation of stability or bioequivalency studies by an applicant."

You may also be interested in...



Maine Senate Race Pits Generic Reformer Against “Maine Rx” Author

The 2002 Maine senatorial campaign features a race between an author of the Senate's generic drug reform bill and a sponsor of legislation creating the "Maine Rx" state drug assistance program

Part D Discount Liability Coming Into Focus: CMS Releases Drug Cost Data

Newly released Medicare Part D data sheds light on the sales hit that branded pharmaceutical manufacturers will face when the coverage gap discount program gets under way in 2011

UsernamePublicRestriction

Register

ID007083

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