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

Dispute Resolution Strategies: FDA Clarifies Which Issues Can Be Appealed

Executive Summary

Matters ripe for appeal above review division level include denial of request for breakthrough therapy designation, revised guidance states, but general advice – such as how to conduct a clinical research program – are not appealable.

Advertisement

Related Content

KemPharm Seeks FDA Dispute Resolution Over Apadaz's Abuse Deterrence
Totality Of ‘Breakthrough’ Evidence Guides FDA Designation Decisions

Topics

Advertisement
UsernamePublicRestriction

Register

PS057144

Ask The Analyst

Please Note: You can also Click below Link for Ask the Analyst
Ask The Analyst

All set! This Question has been sent to 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