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

Off The Clock? The New Timelines Of “Real-Time Review”

Executive Summary

When is a two-week review not a two-week review? When it is part of the US FDA’s Oncology Center of Excellence “real-time review” pilot program. The “left shifted” review pilot is off to a good start, but it may be time to rethink the concept of FDA review clocks.

You may also be interested in...



Top Financings: 2018 Was A Remarkable Year For Biopharma Fundraising

Highlights from the past year's financings include BeiGene's $800m follow-on offering in the US and $903m Hong Kong IPO, Moderna's $560m Series G round and $604m IPO, and Allogene's $300m Series A and $373m IPO.

Reliance On ‘Digitized Paper’ Is Slowing Drug Development – US FDA’s Woodcock

Efficient development and review is being hindered by the inability to exchange data freely and truly capitalize on the digital age, CDER director says, challenging industry, regulators and others to creatively think about how to move away from legacy, paper-based processes in clinical trials and regulatory submissions.

Keeping Track: US FDA Approvals For Tibsovo, Kisqali And Second Neupogen Biosimilar

The latest drug development news and highlights from our US FDA Performance Tracker.

Topics

Related Companies

UsernamePublicRestriction

Register

PS124325

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