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


US Funding Law Could Speed Approval Of Drugs And Biologics Manufactured In Advanced Ways

Executive Summary

FY 2023 appropriations language requires HHS Secretary to designate advanced manufacturing technologies for expedited review, and to follow up with advice and meetings that could help move things along.

You may also be interested in...

US FDA Stance Against Biologics Outsourcing Draws Fire From Cell & Gene Therapy Sector

Groups representing contract manufacturers and cell and gene therapy developers criticized agency’s actions forcing biologics sponsors to grapple with chemistry, manufacturing and controls challenges instead of relying on contract manufacturers’ proprietary technologies.

2023 US FDA Drug Quality Guidance Expected To Include 20-Year CTD Update, Much More

A revision of the ICH Common Technical Document expected this year will set the global stage for eventual “structured” quality submissions. Meanwhile, the FDA plans to complete work on ICH impurities guidance and advanced manufacturing technology guidance.

How US FDA Must Designate Manufacturing Platforms To Help Speed Approvals

Initial product approvals will kick off a process that an FY23 spending bill provision establishes for the pharmaceutical industry to build on prior knowledge from manufacturing platform technologies. But the FDA can only designate platforms that really will expedite the development and review of new drugs and biologics.

Related Content


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