GDUFA II Creates “Complex Generic” Pathway, But Simplifies Review Goals Overall; 8-Month “Priority” ANDA Timeline Set

September 23, 2016

You must be a logged-in member of this site to view this article.

To request more information about a company license to the Prevision Policy continuous information service or to get further details about the services we offer, please click here.

Alternatively, if your organization already has a license and you do not yet have an account, please click here to request access.

Member Login

What is Prevision Policy?

Prevision Policy provides breaking analysis for biopharma on drug regulation, policy and market access. Our continuous information service gives decision makers actionable insight when they need it most on FDA, CMS, Congress, and how developments in policy impact commercial success.

Prevision Policy was started with the belief that information must be trustworthy, interactive, fast as it is deep, and deliver the bottom line. Strategy is developed in real-time and the biopharma business landscape can change quickly and without warning. Our service has been developed to address those challenges and turn them into opportunities.

To request more information about a company license to the Prevision Policy continuous information service or to get further details about the services we offer, please click here.

Request Processed

Register

You must be a logged-in member of this site to view this article.

Member Login