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

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...



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FDA’s draft guidance on “Enrichment Strategies for Clinical Trials” fulfills an overdue goal from PDUFA IV.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.”

FDA’s Temple Sees Sentinel As Important Tool For Confirming And Analyzing Drug Adverse Events

FDA clinical science expert Robert Temple discusses how the Sentinel project – a drug data monitoring initiative – can support the agency’s postmarket drug safety investigations.

Related Content

Topics

Related Companies

UsernamePublicRestriction

Register

PS073322

Ask The Analyst

Please Note: You can also Click below Link for Ask the Analyst
Ask The Analyst

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