We use cookies to deliver the best possible experience on our website. To learn more, visit our Privacy Policy. By continuing to use this site, or closing this box, you consent to our use of cookies.

X

Latest Post

March 02, 2017

GDUFA II is Coming: What it Means for West's Generics Customers

<p style="margin: 0in 0in 10pt;"><span>When the first Generic Drug User Fee Act (GDUFA I) was enacted in 2012, The FDA&rsquo;s Office of Generic drugs (OGD) was trying to&nbsp;manage a growing backlog of regulatory applications. The introduction of user fees to the generic drug approval process permitted FDA to increase resources to address the increasing review and inspection demands. In addition, GDUFA I set forth performance goals for the FDA over a 5-year span, resulting in reductions in both the generic drug application backlog and application review times. </span></p>
Steve LoCastro

Steve LoCastro

Director, Regulatory Affairs

Previous Posts
Fran DeGrazio presenting at Pharmapack 2017

February 17, 2017

Fran DeGrazio Presents on The Changing Regulatory Environment -- Pharmapack 2017

Page McAndrew

Page McAndrew

Director, Scientific Communications

West logo with Diamond

January 31, 2017

West Obtains ISO 15378 Certification in North America

James Rigney

James Rigney

Manager, Quality North America

West logo with Diamond

October 19, 2016

Leaders Round Table Helps Support West's Market-Led Strategy

Taylor Pendergast

Taylor Pendergast

Global Communications Associate Specialist

West logo with Diamond

April 07, 2016

Recent Changes to West’s Elastomer Formulation DMF

Steve LoCastro

Steve LoCastro

Director, Regulatory Affairs

Blue West logo with Diamond

November 06, 2015

Global Regulatory Submission Support Packages for West Customers

Steve LoCastro

Steve LoCastro

Director, Regulatory Affairs

Load more