The Investigational New Drug (IND) phase of drug development is the time during which human trials of investigational drugs are conducted. During this time, IND sponsors and FDA review staff communicate about IND status, questions, and concerns. For the sixth authorization of the Prescription Drug User Fee Act (PDUFA VI), the U.S. Food and Drug Administration (FDA) committed to contracting with an independent third party to assess current practices of FDA and sponsors in communicating during IND drug development and identify best practices and areas of improvement. To that end, the third-party contractor selected, Eastern Research Group, Inc. (ERG), will collect data for a sample of up to 150 active commercial INDs that have activity during a one-year period. ERG will do so by collecting data on the INDs themselves, conducting surveys and interviews with IND sponsors to learn about their experiences, and obtain feedback from FDA reviewer staff. The purpose of this information collection is to understand active commercial IND sponsor perspectives on their communications with FDA review staff. This includes perspectives on what is working well, ongoing challenges and pain points, lessons learned, and opportunities for improvement. The contractor will develop anonymized aggregated summaries of survey and interview responses, analyze this information to identify common themes, consider these results along with IND data and feedback from FDA review staff to develop a set of findings and recommendations, and prepare a report and presentation. FDA will publish the report on the Agency’s public website and hold a public meeting about the assessment. The contractor will keep information collected private; ERG will not disclose personally identifying information to FDA or any other party.
The latest form for Surveys and Interviews with Investigational New Drug Sponsors to Assess Current Communication Practices with FDA Review Staff Under the Sixth Authorization of the Prescription Drug User Fee Act expires 2021-12-31 and can be found here.
Supporting Statement A
Supporting Statement B
Approved with change
|New collection (Request for a new OMB Control Number)||2018-11-19|
Federal Enterprise Architecture: Health - Health Care Services