FDA

Minding the ABC’s of Complex Generic Drugs: Access, Bioequivalence, and Complexity

January 1, 2022

New center strives to help develop generics and patients who need them

FDA Grant Tasks M-CERSI with Reviewing Substances Compounded by Outsourcing Facilities

January 1, 2022

M-CERSI receives grant to study how drug ingredients are combined, mixed, or altered to create tailored medication.

Faculty Members’ Research Impacts FDA Guidance

November 30, 2021

Adjustments on detection method, type of trial should make it easier to gain approval of generic injectable iron drugs.

Center for Research on Complex Generics Holds Inaugural Event

September 20, 2021

More than 2,500 attend virtual conference on IVRT/IVPT methods and uses to support demonstration of bioequivalence.

Grant Increases Access, Safety of Generic Drugs

September 29, 2020

New center established by the School of Pharmacy, in collaboration with the University of Michigan, will increase access to safe and effective generic drugs through collaborative research, training, and exchange.

SOP’s Mattingly Awarded $2.2 Million Grant to Investigate Bulk Drug Substances for Compounding

December 4, 2018

Grant from the U.S. Food and Drug Administration will span three years and include evaluations for more than 200 nominated substances.

M-CERSI Cooperative Agreement Grant Renewed by Food and Drug Administration

October 3, 2018

Latest renewal allows for up to $5 million per year over five years, and will help M-CERSI further advance its mission to promote the development of new tools, standards, and approaches to assess the safety, efficacy, quality, and performance of FDA-regulated products.

CTM, FDA Collaborate to Assess Extrapolation of Anti-Epileptic Drugs’ Effectiveness

March 24, 2016

FDA praises the Center’s efforts to bring academic, government, and industry stakeholders together for collaborative project with wide-reaching implications.

School of Pharmacy Sees Unparalleled Growth in Research Funding

December 7, 2015

New grants and contracts from a multitude of non-profit and government organizations, as well as the private sector, help the School of Pharmacy achieve the highest funding increase among all professional and graduate schools at the University of Maryland, Baltimore.

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