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

FDA’s Disparate Treatment Of Fibrinogen Products ‘Defies Logic,’ Octapharma Contends

Executive Summary

Suit says FDA wrongly classified the fibrinogen products of three blood centers as ‘blood components’ exempt from clinical trials while classifying Octapharma’s Fibryga as a ‘blood derivative’ subject to clinical studies.

You may also be interested in...



Keeping Track: First Gliomas Imaging Agent Wins Approval; Amgen Hopes New Repatha Data Boosts Prospects

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

Poziotinib Fails To Get FDA Panel Support Though Members Not As Dubious As Agency

Agency’s recent approval of Enhertu, which has better response rate, sways some panel members to vote against Spectrum’s NSCLC drug. FDA’s Pazdur compares poziotinib’s dosing uncertainty to ‘building a house on quicksand.’

‘On-And Off-Ramps’ For Cancer Accelerated Approvals: FDA Suggests Earlier Randomized Trials

Leaders of FDA’s oncology center say sponsors could initiate a single randomized trial prior to receiving accelerated approval or conduct a single-group AA study concurrently with a randomized trial. FDA and sponsor could agree in advance on criteria for approval and withdrawal.

Topics

Related Companies

Latest News
See All
UsernamePublicRestriction

Register

PS147008

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