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

Orphan Exclusivity, Drug-Device Designation Court Rulings Against FDA Would Be Fixed In User Fee Bill

Executive Summary

Draft legislation would undo the Catalyst decision prohibiting FDA from providing separate orphan exclusivity periods for different subpopulations and alter the Genus ruling by requiring FDA to treat contrast agents, radioactive drugs and OTC monograph drugs as drugs.

You may also be interested in...



Don’t Call It A Center Of Excellence: Accelerating Rare Disease Cures Program Launched By CDER

‘Umbrella’ program is intended to ensure all rare disease and related programs at CDER are working together, which seems similar to the rare disease center of excellence concept that stakeholders want to coordinate activities across the FDA.

Patient Data In Drug Reviews Would Be Encouraged In Proposed Amendment To User Fee Bill

Rep. Matsui withdrew amendment on FDA’s use of patient experience data during health subcommittee markup of user fee reauthorization legislation, but it may be considered in full committee markup following agency input. Chair Eshoo says the provision specifying contrast agents must be regulated as drugs needs to be reworked to include ophthalmic products.

US FDA Orphan Exclusivity Would Revert To Pre-Catalyst Status Under Senate Legislation

Federal court decision said the FDA cannot grant orphan exclusivity for subpopulations of a disease, which agency officials fear could damage pediatric rare disease drug development.

Related Content

Topics

Related Companies

UsernamePublicRestriction

Register

PS146136

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