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


Pink Sheet Podcast: Janet Woodcock Retiring, Accelerated Approval Reform, US FDA Meeting Recording Policy

Executive Summary

Pink Sheet reporters and editors discuss US FDA Principal Deputy Commissioner Janet Woodcock’s legacy as her retirement approaches, the stance of the FDA’s oncology division on confirming benefit after an accelerated approval, and why formal meetings between the agency and sponsors cannot be recorded.

You may also be interested in...

Pink Sheet Podcast: FTC Orange Book Patent Challenges, Ad/Promo Due Diligence, US FDA Adcomm Decision Appeal

Pink Sheet reporter and editors discuss the FTC’s challenges of Orange Book patents, DTC promotion practices as part of acquisition due diligence, and how Intarcia’s advisory committee decision appeal could play out.

Pink Sheet Podcast: Off-Label Coms Guidance, Price Negotiations And Prescribing, Bertagnolli’s NIH Bid

Pink Sheet reporters and editors discuss new off-label use communications guidance, how price negotiations could impact prescribing, and Monica Bertagnolli’s nomination for NIH director advancing.

Pink Sheet Podcast: Adcomm Rejects NurOwn For ALS, FDA In Shutdown Mode, Limited Price Negotiation Savings

Pink Sheet reporters and editors consider the fallout from Brainstorm Cell Therapeutics Inc.’s negative US FDA advisory committee decision on its ALS drug, the impact of a government shutdown on the agency, and a study showing only a limited possibility for significant savings in the first round of Medicare price negotiations.


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