How Modeling Was Used to Support the FDA Approval of a Topical Generic
CDER Researchers have been investigating how pharmacokinetic (PK) modeling can support a determination of bioequivalence (BE) for topical drug products. In the case of a generic diclofenac sodium topical gel, 1%, CDER found that physiologically based pharmacokinetic...Completed PDUFA VI Deliverables
Assessment in Support of Sentinel SystemPublic Report FDA’s assessment of the Sentinel system including the analysis and reporting of the impact of the Sentinel expansion and integration on FDA’s use of Sentinel for regulatory purposes. Enhancement and modernization...Differences in COVID-19 Fatality Rates among Ethnic Groups, Hawaii, USA, 2020–2022
Disclaimer: Early release articles are not considered as final versions. Any changes will be reflected in the online version in the month the article is officially released. Author affiliation: University of Hawaii John A. Burns School of Medicine, Honolulu, Hawaii,...Retrospective Analysis of Historical Listeria monocytogenes Clinical Isolates, New York, USA, 2000–2021
Disclaimer: Early release articles are not considered as final versions. Any changes will be reflected in the online version in the month the article is officially released. Author affiliation: Cornell University, Ithaca, New York, USA (H. Samut, M. Wiedmann, R.H....Prolonged Monkeypox Virus Infections, California, USA, May 2022–August 2024
Disclaimer: Early release articles are not considered as final versions. Any changes will be reflected in the online version in the month the article is officially released. Author affiliation: University of California School of Medicine, Davis, California (S....Cutaneous Coccidioidomycosis Mimicking Rosacea in Immunosuppressed Patient, Arizona, USA, 2024
Disclaimer: Early release articles are not considered as final versions. Any changes will be reflected in the online version in the month the article is officially released. Cutaneous Coccidioidomycosis Mimicking Rosacea in Immunosuppressed Patient, Arizona, USA, 2024...QM CoE Educational Resources
Discover educational resources available under the QM CoE.FDA/C-Path Institute Model Informed Drug Development Web-Based Training The U.S. Food and Drug Administration’s (FDA’s) Center for Drug Evaluation and Research (CDER) Quantitative Medicine Center of Excellence...Impact Story
CDER research is helping to inform how peptide and protein therapeutics that are not monoclonal antibodies should be regulated.Background and scientific challengeThe most common mechanism of drug-induced QT prolongation[1] and the associated rare, but potentially...Click To Verify Security & Validation
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