Impact Story

by Pill Pals Customer Service | Sep 12, 2025 | News

CDER researchers have conducted a randomized study to better understand how physicians make prescribing decisions.As they make decisions about which drug products should be prescribed to their patients, physicians must process a great deal of relevant information in a...

How Modeling Was Used to Support the FDA Approval of a Topical Generic

by Pill Pals Customer Service | Sep 12, 2025 | News

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

by Pill Pals Customer Service | Sep 12, 2025 | News

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

by Pill Pals Customer Service | Sep 11, 2025 | News

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

by Pill Pals Customer Service | Sep 11, 2025 | News

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....