Rx REPORT

Monitoring and Reporting Working Group Posts New Resources

The Monitoring and Reporting Group has just launched three more resources to the resource library.

We invite you to share these with colleagues and friends:

FDA Office of Generic Drugs Issues 2016 Annual Report

On February 28, 2017, FDA’s Office of Generic Drugs (OGD) posted its 2016 annual report.  The report discusses Generic Drug User Fee Amendments (GDUFA), guidances and standards, enhancing communication with industry and stakeholders, approval and other regulatory actions, and 2016 GDUFA Regulatory Science Plan.

CDER Issues Updated CY2017 Guidance Agenda

CDER has issued their updated CY2017 Guidance Agenda (issued February 15, 2017), which outlines new and revised draft guidances CDER plans to publish during the year.

FDA Medical Device Inspection Observation Summary Published

FDA has recently published their Medical Device Inspectional Observation Summary for FY2016.  This information can assist industry in improving device quality and compliance.