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

RAT Race Begins: FDA Accepting Regenerative Advanced Therapy Designation Requests

Executive Summary

As part of a flurry of actions in the waning days of the Obama Administration, FDA formally announced a process for requesting the new “Regenerative Advanced Therapy” designation. Much like the early days of “Breakthrough,” the standards are uncertain for now.

You may also be interested in...



Regenerative Medicine Clinical Trials: US FDA Supports Studies Comparing Multiple Agents

Draft guidance suggests comparing therapies for a rare disease to each other and active control, offers examples of novel efficacy endpoints and what therapies may qualify for breakthrough and RMAT designations.

CAR-T Cancer Drugs Front And Center At ARM Investor Day

Labeling, logistics and other issues were on the table as industry experts discussed the potential upcoming launches of CAR-T therapies in the US. Datamonitor Healthcare reported live from the ARM conference.

FDA's Document Dump: Guidance Release Skyrockets Ahead Of Trump's Arrival

Uncertainty about US FDA's direction under the new president may have spurred staff to ensure views on several issues released before administration changed.

Related Content

Topics

UsernamePublicRestriction

Register

PS119938

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