Pink Sheet is part of Informa PLC

This site is operated by a business or businesses owned by Informa PLC and all copyright resides with them. Informa PLC’s registered office is 5 Howick Place, London SW1P 1WG. Registered in England and Wales. Number 8860726.

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
UsernamePublicRestriction

Crackdown On Bad Regenerative Medicine Could Benefit Gene Therapy

Executive Summary

US FDA to offer series of guidances on regenerative product development – and declares gene therapies eligible for RMAT – as enforcement against 'unscrupulous actors' continues.

You may also be interested in...



FDA Ups Pressure On Stem Cell Therapy Makers To Follow Product Approval Rules

US FDA is frustrated that few stem cell therapy makers are seeking regulatory approval of their products during the current enforcement grace period. 

Initiator Or Facilitator? Gottlieb Reflects On First Year As Head Of US FDA

In interview with the Pink Sheet, Commissioner Gottlieb credits career staff, not his leadership, with many of the policy shifts.

Gottlieb On Gene Therapies: 'Very Seductive' To Think About Accelerated Approval Pathway

Accelerated approval would help agency monitor gene therapies for durability and off-target effects, US FDA commissioner says.

Related Content

Topics

UsernamePublicRestriction

Register

PS121414

Ask The Analyst

Please Note: You can also Click below Link for Ask the Analyst
Ask The Analyst

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