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

Coronavirus Notebook: US FDA's Paper Push, Industry Execs/US Officials Emphasize Their Collaboration

Executive Summary

Dispatches from a world turned upside down include the US FDA expressing confidence in Chinese manufacturers – to make their GDUFA payments; projections of drug shortages for ventilator patients; and the launch of new hydroxychloroquine studies.

You may also be interested in...



Taking The ‘O’ Out Of RTOR: US FDA’s Real-Time Review Primed For Expansion Beyond Oncology

Technology modernization efforts, the expansion of cloud-based submission capabilities, and the ongoing COVID-19 pandemic could serve as catalysts to broaden FDA’s Real-Time Oncology Review program beyond cancer therapeutics, Pfizer exec Richard Jahn says.

US FDA Waives Warning Cap Requirement For Neuromuscular Agents As Demand Outranks Safety Worries

COVID-driven supply shortages were both the cause of and solution to production deficiencies for manufacturers of neuromuscular blocking agents; US FDA is permitting Mylan, Gland, and Fresenius Kabi to distribute vecuronium bromide and rocuronium bromide even though they do not have the paralyzing agent’ warning on the caps since the products are in high demand at ICUs. The appropriately embossed caps were unavailable due to supply chain disruptions caused by the pandemic.

Trump’s Rhetorical Pivot On Pharma: The Hucksterism Is Still A Threat

It is nice for pharma CEOs to be called ‘brilliant’ by a President who once said they are ‘getting away with murder.’ But the ‘new’ Trump rhetoric still has major pitfalls for industry – including a fundamental risk of undermining regulatory standards.

Related Content

Topics

Related Companies

Latest Headlines
See All
UsernamePublicRestriction

Register

PS141993

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