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

Unapproved Cell/Tissue Product Enforcement Discretion Ends; How Hard Will US FDA Crack Down?

Executive Summary

Entities that already have received letters from the agency raising concerns about marketing unapproved products may not necessarily be the first to face enforcement actions, CBER official says.

You may also be interested in...



FDA Court Loss Shows ‘Disconnect’ Between Old Regulatory Language And Cell Therapy Technology

That statutory regulatory language never quite keeps up with change in science is an ‘existential crisis,’ former FDA official says. California district court ruling preventing FDA enforcement action against stem cell clinics was ‘a little bit disrespectful to the agency.’

Drugs From Sponsors ‘Located in Russia,’ Would Be Barred From US FDA Review By House Funding Bill

Language of the amendment cleared by appropriators in response to the Russian war against Ukraine in FDA’s fiscal year funding bill is vague, making impact of the funding ban on industry unclear. Democrats supported the amendment but said they wanted to continue to work on language to avoid “unintended consequences.” FDA would get a 10% bump in non-user fee funds under the bill.

US FDA To Explore New Regulatory Pathways For Some Cellular Products

Agency re-evaluating criteria for certain human cells, tissues and cellular and tissue-based products (HCT/Ps) that are not ideally regulated as BLAs; industry suggests a 2014 guidance which created an alternative pathway for cord blood products could serve as potential template.

Related Content

Topics

Latest News
See All
UsernamePublicRestriction

Register

PS144382

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