FDA

CERSI Symposium Highlights Use of Biomarkers in Drug Development

August 28, 2015

More than 500 researchers from academia, government, and industry gather to gain perspective on biomarker development and the application of biomarkers in preclinical and clinical research.

SOP’s Polli Testifies for GDUFA Renewal at National Public Meeting

August 6, 2015

Testimony examined the impact of FDA-supported research in generic drugs and advocated for continued funding through renewal of the Generic Drug User Fee Amendments of 2012 (GDUFA).

SOP Faculty Receive $1.5 Million from the FDA to Study Iron Medications

February 24, 2015

Interdisciplinary group will research the effectiveness of brand versus generic iron medications used to treat anemia in kidney disease patients

FDA Awards Two Grants, $1.2 Million to Center for Translational Medicine

January 12, 2015

Grants will support the development of quantitative pharmacometric models to advance the evaluation of generic drugs.

CERSI-Sponsored Conference Brings “Big Data” Experts to UMB

February 25, 2014

Researchers from academia, government, and industry discuss how increasingly large, complex datasets can be harnessed to improve the drug development process.

SOP Talent Competition Highlights Student Innovation in Regulatory Science

February 6, 2014

M-CERSI’s “America’s Got Regulatory Science Talent” judges award student first prize for new technology to combat worldwide counterfeit drug crisis.

SOP Awarded Federal Contract to Study Abuse Deterrence of Opioid Drugs

November 6, 2013

Research seeks to improve formulation and manufacturing of opioid medications; deter individuals from abusing powerful pain relievers.

Grants Totaling a Potential $5M Awarded to SOP Researcher

October 10, 2013

Audra Stinchcomb, PhD, will use awards to advance transdermal and topical drug delivery research.

School of Pharmacy Hosts Second Annual M-CERSI Day

September 13, 2013

Forum brings together FDA scientists, the University of Maryland community, and members of the public to discuss current issues in regulatory science and ongoing M-CERSI research, training, and exchange activities.

SOP Faculty Testify During FDA Generic Drug Regulation Public Meeting

July 3, 2013

Drs. Hoag and Polli examine current regulatory science initiatives aimed at generic drugs and discuss ways in which existing initiatives can be improved.

UM School of Pharmacy Hosts Successful Korean/FDA Workshop

April 3, 2013

Pharma officials from South Korea visit with the School’s faculty, eye space in University of Maryland BioPark, and help educate many of the School’s students for a week.

Student Talent Competition Focuses on Improvements in Regulatory Science

February 5, 2013

“America’s Got Regulatory Science Talent” judges award student first prize for his guidelines to improve reporting of adverse medication events to the Food and Drug Administration.