FDA to Host Live/Virtual Workshop on Post-Approval Studies Next Week
August 24, 2012
The Food and Drug Administration (FDA) will host a public workshop entitled" Post-Approval Studies 2012 Workshop: Design, Methodology, and Role in Evidence Appraisal throughout the Total Product Life Cycle" on Thursday, August 30.
The topics of discussion will include the following:
- Post-approval studies in the Total Product Life Cycle;
- Best practices and improvement of implementation strategies for post-approval studies; and
- Public health impact and innovative methodologies for evidence appraisal.
FDA is holding this public workshop to provide updates and obtain stakeholder input on Post-Approval Studies ordered at the time of device approval. This program will be held live on the FDA White Oak Campus in Silver Spring, MD as well as webcast.