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

Patient Advocacy With FDA Review Staff Will Be Tougher Post-Sarepta

Executive Summary

Efforts by CDER management to encourage more interaction between patients and FDA reviewers may be part of the collateral damage from the difficult FDA review of Sarepta’s Exondys 51. The hopes of parents of boys with DMD pushed the regulatory flexibility by CDER management on this application – but may end up limiting the willingness of FDA reviewers to engage with patients in the future.

You may also be interested in...



Sarepta Tells Patients To Stand Down, Golodirsen Future 'Our Responsibility'

Patient advocates asked what they could do after US FDA’s complete response letter for the proposed Duchenne drug, but Sarepta's CEO said the company would get the product back on track to approval itself, a marked contrast to engaged role the community played the last time the firm ran into a roadblock at the agency.

FDA Ends Regularly Scheduled Patient-Focused Drug Development Meetings

After conducting 24 disease-focused meetings in five years, FDA moving to next phase of patient interaction under new user fee cycle.

Woodcock's 'Bias' In Sarepta Case Made Jenkins Worry About Future Drug Reviews

In memo to then-Commissioner Califf during review of Sarepta's Exondys 51, Jenkins wrote that he was concerned about leaving OND in hands of CDER director upon his retirement.

Related Content

Topics

UsernamePublicRestriction

Register

PS119191

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