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


Unger Takes Over ODE I As Acting Director; Temple To Focus On Clinical Science Role

This article was originally published in The Pink Sheet Daily

You may also be interested in...

Changing Of The Guard At US FDA Continues With Unger Retirement

One of the US FDA’s most prominent review managers is retiring after nearly 25 years with the agency. Ellis Unger’s departure underscores a sense of transition in the leadership and mindset of the drug center.

Invaluable Guidance: FDA’s Dean of Drug Reviews on “Enrichment Strategies”

FDA’s draft guidance on “Enrichment Strategies for Clinical Trials” fulfills an overdue goal from PDUFA IV. It also captures decades of wisdom from the agency’s senior drug review manager.

Chelsea Took Proactive PR Approach For Northera Panel, But Will It Help Or Hurt?

The company held an investor presentation 10 days before the meeting to rebut criticisms laid out in FDA’s briefing document about the droxidopa safety and efficacy data. Immediately following the meeting, Chelsea hosted an investor call, during which the company’s external cardiology consultant criticized the FDA clinical reviewer as “naive.”

Related Content


Related Companies

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