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

EU Generic Approvals Could Accelerate By Two Years With Bolar Changes

Executive Summary

The European Commission's proposed patent reforms could accelerate the approval of generic drugs by two years.

You may also be interested in...



FDA "Compassionate Use" Rule Will Outline Access Options Outside Trials

FDA is developing a rule to describe criteria for a range of ways to offer drug treatment options to patients not participating in clinical trials.

Amarin NDA For CeNeS Morphine Suppository Planned For Second-Half 2002

Amarin expects to file an NDA for the morphine-releasing rectal suppository Moraxen by second-half 2002.

EU To Revise Oncologics Guidelines To Increase Cancer Product Approvals

The European Committee on Proprietary Medicinal Products is considering revisions to its guidelines for oncologic products that would help accelerate the development and approval of anticancer agents.

UsernamePublicRestriction

Register

OM006922

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