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
January 1, 2022
New center strives to help develop generics and patients who need them
January 1, 2022
M-CERSI receives grant to study how drug ingredients are combined, mixed, or altered to create tailored medication.
November 30, 2021
Adjustments on detection method, type of trial should make it easier to gain approval of generic injectable iron drugs.
September 20, 2021
More than 2,500 attend virtual conference on IVRT/IVPT methods and uses to support demonstration of bioequivalence.
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.
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.
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.
March 24, 2016
FDA praises the Center’s efforts to bring academic, government, and industry stakeholders together for collaborative project with wide-reaching implications.
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.
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.
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).
February 24, 2015
Interdisciplinary group will research the effectiveness of brand versus generic iron medications used to treat anemia in kidney disease patients