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

UsernamePublicRestriction

China Unlikely To Be Included In US FDA's Project Orbis In The Near Term

Executive Summary

Oncology Center of Excellence Director Pazdur says there must be confidence that confidentiality agreements are universally accepted in response to request that China be included in the multi-regulator application assessment program.

You may also be interested in...



Drug Review Times Are Not Shortened Much By Single Expedited Review Designation

Government Accountability Office also finds that US FDA review divisions are largely consistent in their assessment times after controlling for goal dates and expedited programs.

Oncology Drug Safety Is Key Focus In US FDA’s Generic Label Updates

US FDA’s ‘Project Renewal’ requires lots of work and flexibility, Oncology Center of Excellence acknowledges. Side-benefit may be getting outside physicians to appreciate the value of drug labeling.

Novel Virus Brings Novel Threats To Global Pharmaceutical Manufacturing

As coronavirus spreads into China’s manufacturing region, quarantines and travel restrictions challenge international flow of pharmaceuticals, ingredients and personnel.

Related Content

Topics

Related Companies

Latest News
UsernamePublicRestriction

Register

PS141641

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