Pink Sheet is part of the Business Intelligence Division 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

‘Regulatory Risk’: A New Factor In Risk/Benefit Equation At US FDA?

Executive Summary

FDA’s evolving efforts to develop a ‘structured risk-benefit’ framework is playing an important role in accelerating access to drugs for rare diseases and specific subgroups in cancer; there may be less attention to an accompanying phrase that is growing in currency as a factor in the equation: ‘regulatory risk’ – the term for how FDA calculates the odds of making the wrong regulatory decision for a small-population treatment.

Advertisement

Related Content

Lilly's Lartruvo Scores Broad FDA Approval In Orphan Sarcomas
Accelerated Approval After Eteplirsen: A Lowered Bar Or A Unique Event?

Topics

Related Companies

Advertisement
UsernamePublicRestriction

Register

PS119598

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