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

Executive Summary

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.’

You may also be interested in...



US FDA’s Stem Cell Clinic Enforcement Takes A Hit With Loss In California Case

Federal judge denies government’s request to permanently enjoin California stem cell clinic from administering unapproved stromal vascular stem cell treatments, concluding they are not ‘drugs’ under the FD&CA. Ruling runs counter to decision in similar case involving a Florida stem cell clinic.

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.

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

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.

Topics

Latest Headlines
See All
UsernamePublicRestriction

Register

PS147190

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