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

In Brief: GDUFA inspections, FDA’s inspection workforce, device warning letters, 3D drug printers, CMC/GMP guidance agenda

This article was originally published in The Gold Sheet

Executive Summary

FDA discusses GDUFA II inspectional transparency issues with industry; FDA plans global workforce; device warning letter rate fell; why FDA needs a 3D drug printer; and CMC trumps GMP in FDA agenda.

You may also be interested in...



GDUFA II: Inspection Information Takes Center Stage

Sponsors say transparency is important as generic drug user fee negotiations move to inspection policy.

Scrip M&A Podcast: Which Companies Could Be Acquired Next?

The editorial team from Scrip discusses the M&A potential of various emerging biopharmas, such as Viking, Verona, Altimmune, Xenon and Crinetics.

New EU Filings

Obecabtagene autoleucel, Autolus Therapeutics’s investigational treatment for relapsed or refractory B cell precursor acute lymphoblastic leukemia, is among the latest products that have been filed for review by the European Medicines Agency for potential EU marketing approval.

Topics

Latest Headlines
See All
UsernamePublicRestriction

Register

PS000960

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