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

Minding The Gap: Pazdur Compares FDA, EMEA Approaches

Executive Summary

ORLANDO, Fla. - "EMEA is not the FDA of Europe, and the FDA is not the EMEA of the United States." That's how Richard Pazdur - the head of FDA's Office of Oncology Drug Products - started off a panel on oncology regulatory initiatives at ASCO on May 30

You may also be interested in...



Myovant’s Relugolix Won’t Be Stopped By Missed Endpoint

The miss on improving castration resistance-free survival in Phase III trial is not likely to affect the ongoing FDA review, the company and analysts agree.

BI Finds Right Fit For Digital Therapeutic Partnership With Click

Deal Snapshot: The firms are partnering on a digital therapeutic for schizophrenia in a deal potentially worth $500m. 

Consumer Health Brands Will Be Included In Bausch's Spin-Out Of Bausch Part Of Company

“The spin-off will establish two separate companies, a fully integrated, pure play, eye health company built on the iconic Bausch Health brand and a long history of innovation, and an international diversified pharmaceutical company with leading physicians in gastroenterology, dermatology, aesthetics, neurology and an international pharma business,” says CEO Joseph Papa.

Topics

UsernamePublicRestriction

Register

LL1135415

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