Pink Sheet is part of Pharma Intelligence UK Limited

This site is operated by Pharma Intelligence UK Limited, a company registered in England and Wales with company number 13787459 whose registered office is 5 Howick Place, London SW1P 1WG. The Pharma Intelligence group is owned by Caerus Topco S.à r.l. and all copyright resides with the group.

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


Complex Generic Sponsors Not Using US FDA-EMA Parallel Scientific Advice Program

Executive Summary

After nearly two years, the program has received only two requests, driving FDA officials to try to boost interest.

You may also be interested in...

EMA Picks Antibiotic Combo & RSV Vaccine For New International Parallel Review Framework

The first products to be selected for review under the European Medicines Agency’s newly extended OPEN framework for collaboratively assessing marketing applications with non-EU authorities are from Pfizer/AbbVie and Moderna.

EMA Will Observe Project Orbis In Effort To Increase Collaboration

The goal is for EMA officials to better understand the process, but becoming an official member still may prove difficult because of the EMA regulatory scheme.

Generics Industry Welcomes Fresh ICH Harmonization Initiative

The International Council for Harmonisation has unveiled plans to develop and publish several new guidance documents, including one on bioequivalence for modified-release products, which has been welcomed by global off-patent industry body the IGBA.

Related Content


Latest Headlines
See All



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