USFDA announced Fiscal Year 2015 "Regulatory Science Priorities" under the "Generic Drug User Fee Amendments (GDUFA)" of 2012

U.S. Food and Drug Administration (FDA) has published the fiscal year 2015 "Regulatory Science Priorities" for generic drugs.   

FY 2015 Research Priorities List was prepared based on a public meeting held on May 16, 2014, where comments submitted to the public docket, scientific issues raised in citizen petitions, meeting request and controlled correspondence topics, tracked safety issues and discussions within FDA's Center for Drug Evaluation and Research.

To comply with this GDUFA requirement, the FDA Office of Generic Drugs developed the following fiscal year (FY) 2015 regulatory science priorities for generic drugs:

• Post-market evaluation of generic drugs
• Equivalence of complex products
• Equivalence of locally-acting products
• Therapeutic equivalence evaluation and standards
• Computational and analytical tools 

For detailed information on "Fiscal Year 2015 Regulatory Science Priorities" CLICK HERE