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

Gottlieb's "Right To Try" Sentiment: Law Fails To Address Difficulties Faced By Drugmakers

Executive Summary

US FDA Commissioner suggests Congress may need to explore incentives for drugmakers to make investigational products available in the pre-approval phase. 

You may also be interested in...



Passive Adverse Event Approach Is Key Facet Of US FDA's Right-To-Try Rule

Sponsors will have little obligation to conduct due diligence of adverse events experienced with right-to-try drug use under a proposed FDA rule, leading critics to once again raise safety concerns with the pathway for accessing experimental medicines. The agency will not help patients or companies determine whether drugs qualify for right-to-try.

Right To Try Conversation Should Be Redirected Toward Reimbursement Of Unapproved Drugs, Experts Say

King & Spalding Partner David Farber called for amending Medicare and Medicaid statutes so that unapproved treatments can be reimbursed for terminally ill patients who have exhausted all other options.

Next Step After 'Right To Try'? Senate Hearing Includes Call To Reopen Orphan Drug Act

Trump Administration’s successful campaign to pass “Right to Try” legislation may be emboldening advocates to push for other policies that will loosen FDA regulatory requirements on rare disease drug development.

Related Content

Topics

Latest Headlines
See All
UsernamePublicRestriction

Register

PS123596

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