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

Vimizim Voucher A Result Of BioMarin’s Late Request, FDA Flexibility

Executive Summary

Sponsors of rare pediatric disease treatments should be buoyed by news that FDA’s Office of Orphan Products Development liberally interpreted the FDASIA language that requires priority review vouchers be given only when an indication is limited to a pediatric population.

Advertisement

Related Content

Sponsors May Race For Rare Pediatric Voucher Designations As Deadline Nears
How Much Is A Priority Review Worth? $67.5 Million, Sanofi/Regeneron Say
BioMarin Tests FDASIA’s Pediatric Voucher Waters With Vimizim Approval

Topics

Related Companies

Advertisement
UsernamePublicRestriction

Register

PS056307

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