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

US bill seeks to improve use of accelerated approval pathway for ultra-rare drugs

This article was originally published in SRA

Executive Summary

US lawmakers have introduced a bill designed to improve access to the Food and Drug Administration's accelerated approval pathway for medicines designed to treat life-threatening, ultra-rare diseases1,2.

You may also be interested in...



Migraine & Hepatitis B Prevention Products Among New EU Filings

The latest list of marketing authorization applications under review by the European Medicines Agency includes filings for eight new products.

Another EU Filing Targets Burgeoning NMOSD Market

Viela and Roche both now have marketing applications that are being reviewed by the European Medicines Agency. If approved in the EU, their products will compete with Alexion’s blockbuster Soliris.

Big Changes Kicking In Under Australia’s Personalized Medical Devices Rules

Most of the products currently supplied under Australia’s custom-made medical device exemption will no longer be eligible for supply in this way.

UsernamePublicRestriction

Register

LL1135415

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