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

ISTA’s Bromday Hearing Request Should Be Deferred Pending Cmte. Review, CDER Says

This article was originally published in The Pink Sheet Daily

Executive Summary

Center for Drug Evaluation and Research tells FDA Commissioner Margaret Hamburg that resource and regulatory policy considerations warrant postponing action on ISTA’s request for a formal evidentiary hearing on its rejected application for a larger fill size.

Advertisement

Related Content

ThromboGenics’ Jetrea Clears Advisory Committee On Strength Of Unmet Need
Specter of Bromday Dispute Will Haunt Advisory Panel Discussion of Ophthalmic Product Labeling Changes
Valeant’s Latest M&A Gambit Hits Snag With Ista’s Rejection Of $314 Million Buyout Offer
Avastin Loses Its Breast Cancer Claim; FDA’s Hamburg Opts For Withdrawal Over Restrictions
Bromday Battle Broadens: Ocular Drug Infection Risks, Fill Size Limits Will Get FDA Cmte. Scrutiny
Shire’s Request For ProAmatine Hearing Will Go Unanswered Until 2012
Safety Concerns Over Larger Bottle For ISTA's Bromday Could Impact Other Eye Drugs

Topics

Related Companies

Advertisement
UsernamePublicRestriction

Register

PS073121

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