Understanding Regulatory Requirements in Today’s Accelerated Approval Environment

August 23, 2017

Accelerated regulatory pathways for the development of new drugs in the U.S., Europe, and Japan –
intended to bring important new treatments to patients more quickly – have multiplied in recent years, offering opportunities, benefits, and challenges for developers, patients, regulators, and payers. Learn how to navigate these pathways in a relatively fragmented global regulatory and reimbursement environment.

Previous Flipbook
Strategies for Working with Global Regulatory Agencies
Strategies for Working with Global Regulatory Agencies

Early engagement with regulatory authorities can help boost regulatory success rates and also help shorten ...

Next Flipbook
Phase III Trial Failures: Costly But Preventable
Phase III Trial Failures: Costly But Preventable

This article examines reasons for the high failure rate of Phase III studies and innovative approaches comp...