Center for Drug Evaluation and Research

223207: Reduction in FDA approval time for the fastest 50 percent of standard New Molecular Entities/Biologics Licensing Applications approved for CDER and CBER, using the 3-year submission cohort for FY 2005-2007. (Outcome)

2007

514 days

392 days

(Target Met)

2006

N/A

456 days

(Historical Actual)

2005

N/A

639 days

(Historical Actual)

223208: Reduction in FDA time to approval or tentative approval for the fastest 70 percent of original generic drug applications approved or tentatively approved of those submitted using the 3-year submission cohort for FY 2005-2007. (Outcome)

2007

16.4 months

19.8 months

(Target Not Met)

2006

N/A

17.4 months

(Historical Actual)

2005

N/A

17.8 months
(Historical Actual)

National Center for Toxicological Research

264201: Develop standard biomarkers to establish risk measures for FDA-regulated products. (Output)

2012

N/A

N/A

2011

N/A

N/A

2010

1) MicroArray Quality Control (MAQC)—develop draft guidelines for applying microarray standards

2) Identify gender-specific biomarkers that enable improved risk/benefit decisions for treatments

1) MAQC-II completed, findings published, and NCTR is currently  engaging the scientific community to develop guidelines to ensure the reproducibility of genomic research

(Target Met)

2) Identified 1,640 different sex-expressed genes, all potential sex-specific biomarkers for improved risk/benefit decisions.

(Target Met)

2009

Evaluate biological effects of manganese nanoparticles

Publish research paper showing manganese, copper, and silver nanoparticles altered 11 genes associated with neuro-degeneration (Target Met)

2008

Develop microarray data standards

Submitted 15 manuscripts on the MAQC-II results and published four manuscripts (Target Met)

2007

Conduct research on carbon nanomaterials methods and ketamine

1) Initiated ketamine-induced neurotoxicity in primate model 

(Target Met)

2) Developed synthesis methods for nanotubes (Target Met)