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

FDA’s Breakthrough Products: Could Patients Drive The Designations?

This article was originally published in The Pink Sheet Daily

Executive Summary

Sen. Bennet is receiving letters from patients asking to talk with FDA about products they think could be a breakthrough.

You may also be interested in...



PDUFA VII Already: Could Breakthrough Ideas Apply Outside Program?

Success of enhanced communications in particular made one stakeholder wonder whether FDA could use it with non-breakthrough applications.

FDA Strains Under New NDA Review Model; Will Industry Want To Retain It?

Scheduling mid- and late-cycle meetings complicates reviews for FDA, but the fate of the “Program” probably depends on whether industry feels the extra two months produces better outcomes.

“Patient Voice” Report Puts Chronic Fatigue Symptoms, Treatments In Benefit/Risk Framework

FDA report on CFS/myalgic encephalomyelitis is first of its kind from the patient-focused drug development initiative under PDUFA V. Incorporating comments from hundreds of patients and caregivers into a structured framework shows how the input may support a benefit/risk assessment for new products.

Related Content

Topics

Related Companies

UsernamePublicRestriction

Register

PS076957

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