GDUFA Guidance Document/ Public Workshop on the Use of Real World Evidence

GDUFA Guidance Document/ Public Workshop on the Use of Real World Evidence

1. Generic Drug User Fee Amendments of 2012: Questions and Answers Related to Self-Identification of Facilities, Review of Generic Drug Submissions, and Inspections and Compliance; Guidance for Industry

FDA has issued this guidance document to provide answers to questions arising from the implementation of the Generic Drug User Fee Amendments of 2012 (GDUFA). FDA is issuing the final guidance as two separate guidances. This guidance includes questions and answers related to self-identification, review of generic drug submissions, and inspections and compliance. It clarifies some of the questions and answers included in the previous versions based on FDA’s experience in implementing GDUFA. Questions and answers related to GDUFA’s user fee provisions that appeared in draft versions of this guidance appear in updated form in Guidance for Industry: Generic Drug User Fee Amendments of 2012: Questions and Answers Related to User Fee Assessments (Nov. 21, 2016). 

The questions and answers are grouped below in the following categories:

• Self-identification of facilities, sites and organizations 
• Review of generic drug submissions 
• Inspections and compliance 

This guidance is one in a series of GDUFA communications. Other communications, including guidances and Federal Register notices are available on our GDUFA webpage.

2. Developing a Framework for Regulatory Use of Real-World Evidence; Public Workshop

The FDA is announcing the following public workshop entitled ‘‘Developing a Framework for Regulatory Use of Real-World Evidence.’’ Convened by the Duke-Robert J. Margolis, MD, Center for Health Policy at Duke University and supported by a cooperative agreement with FDA, the purpose of the public workshop is to bring the stakeholder community together to discuss a variety of topics related to the use of real-world data (RWD) and real-world evidence (RWE) in drug development and regulatory decision making. Topics will include an update on FDA’s activities to address the use of RWE in regulatory decisions and the development of a framework for tackling challenges related to RWE’s regulatory acceptability. In addition, panelists will discuss opportunities to improve data development activities, study designs, and analytical methods used to create robust RWE.

The public workshop will be held on September 13, 2017, from 9 AM to 4:30 PM Eastern Time at the Conference Center at 1777 F Street NW., Washington, DC 20006. There will also be a live webcast for those unable to attend the meeting in person.

For additional information, please refer to the following Web site: https://healthpolicy.duke.edu/events/publicworkshop-developing-frameworkregulatory-use-real-world-evidence