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

Expanded Access: FDA To Clarify How Adverse Events Impact Drug Approval Process

Executive Summary

GAO says lack of clear information from FDA may influence whether manufacturers grant expanded access to investigational drugs; only two clinical holds have been due to adverse events from expanded access use.

You may also be interested in...



Expanded Access Data Supported Lutathera Approval, US FDA Notes

Amid broader debate on right-to-try legislation, review experience of Novartis' oncologic highlights US FDA's argument that expanded access can at least in part contribute to approval of a drug.

Right-To-Try Legislation Must Change Language To Narrow Spectrum Of Patients, Gottlieb Says

US FDA commissioner tells House hearing that the Senate's legislation in its current form could undermine the intent of addressing terminally ill patients.

FDA Policy Says Right-to-Try Talks Are Between Providers, Sponsors

New internal policy says the US agency cannot force a drug maker to supply an unapproved drug to a patient for expanded access and that the provider must seek company approval to provide the product.

Related Content

Topics

Related Companies

UsernamePublicRestriction

Register

PS121110

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