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

Expanded Access Programs Need FDA Policy Changes To Really Expand

Executive Summary

Agency should issue statement that deaths occurring during compassionate use will not automatically penalize a drug's development, ethicists from NYU Langone Medical Center say.

You may also be interested in...



Expanded Access: US FDA Told To Increase Regulatory Clarity, Early Interactions With Sponsors

Independent assessment finds positive perceptions of expanded access program but calls on agency to do more to correct manufacturer misperceptions about adverse events and clarify when data from expanded access would support labeling extensions.

Expanded Access Programs Eyed For Data-Gathering Purposes

Protocol-driven approach could generate reliable data about investigational drug's efficacy and safety in patients who do not qualify for clinical trials, PhRMA's Moscicki says; Johns Hopkins' Sharfstein cautions this could turn expanded access programs into burdensome studies that take away from primary purpose of providing access to investigational therapies.

Moscicki, One Of US FDA's Industry Connections, Moves To PhRMA

One of the faces of FDA's effort to recruit senior leaders from outside its walls has decided to return to industry.

Related Content

Topics

Related Companies

UsernamePublicRestriction

Register

PS057650

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