White Paper

Improving Regulatory And Operational Performance In Orphan Drug Development

Source: Premier Research
Business Group Meeting

Today, more than ever, regulatory bodies are providing a progressive platform for rare disease drug development. Extensions to existing regulations and incentives and attempts to reduce orphan drug designation applications provide an unprecedented collaborative environment for companies developing orphan drugs.

The U.S. Food and Drug Administration (FDA) is introducing new review cycles and initiatives to aid researchers, and regulators in other countries will likely follow suit with similar measures to promote orphan drug development. Understanding the regulatory landscape in orphan drug development – specifically the various pathways, incentives, and engagement opportunities with regulators – can help optimize the process and bring therapies to market faster. Sponsors stand to gain by seeking FDA engagement early and often, performing relevant studies

access the White Paper!

Get unlimited access to:

Trend and Thought Leadership Articles
Case Studies & White Papers
Extensive Product Database
Members-Only Premium Content
Welcome Back! Please Log In to Continue. X

Enter your credentials below to log in. Not yet a member of Clinical Leader? Subscribe today.

Subscribe to Clinical Leader X

Please enter your email address and create a password to access the full content, Or log in to your account to continue.

or

Subscribe to Clinical Leader