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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.